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Clinical Trial Results:
A Phase 2A, Multi-Center, Open-Label, Uncontrolled Study to Determine the Safety, Tolerability, and Pharmacokinetics of fidaxomicin Oral Suspension or Tablets in Pediatric Subjects With Clostridium difficile-associated Diarrhea

Summary
EudraCT number	2013-001448-75
Trial protocol	Outside EU/EEA
Global end of trial date	07 Mar 2014

Results information
Results version number	v2(current)
This version publication date	11 Jun 2016
First version publication date	13 Jun 2015
Other versions	v1
Version creation reason	New data added to full data set Added data in the Adverse Events section.

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

OPT-80-206

ISRCTN number

US NCT number

NCT01591863

WHO universal trial number (UTN)

Sponsor organisation name

Optimer Pharmaceuticals (a Cubist company)

Sponsor organisation address

4747 Executive Dr. Ste 1100, San Diego, CA, United States, 92121

Public contact

Clinical Trial Disclosure, Astellas Pharma Global Developmnet, Inc., Astellas.resultsdisclosure@astellas.com

Scientific contact

Clinical Trial Disclosure, Astellas Pharma Global Development, Inc., Astellas.resultsdisclosure@astellas.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-000636-PIP01-09

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

07 Mar 2014

Is this the analysis of the primary completion data?

Yes

Primary completion date

07 Mar 2014

Global end of trial reached?

Yes

Global end of trial date

07 Mar 2014

Was the trial ended prematurely?

Main objective of the trial

The primary objective of this study was to investigate the safety, tolerability, and pharmacokinetics of fidaxomicin oral suspension or tablets in pediatric subjects, aged 6 months to 17 years, 11 months, with Clostridium difficile-associated diarrhea (CDAD), following the administration of doses given every 12 hours for 10 consecutive days. Both plasma and fecal PK analyses were performed.

Protection of trial subjects

This clinical study was written, conducted and reported in accordance with the protocol, ICH GCP Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.

Background therapy

Evidence for comparator

Actual start date of recruitment

12 Oct 2012

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 3

Country: Number of subjects enrolled

United States: 35

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Participants diagnosed with CDAD, defined by (1) a positive stool C.difficile Toxin A and/or Toxin B assay result within 48 hours of enrollment; (2) in the 24 hours prior to enrollment: participants 6-23 months: >3 episodes of watery diarrhea; participants 2 years-17 years 11 months: A change in bowel habits, with >3 unformed bowel movements.

Period 1 title

Overall study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Fidaxomicin 6-23 Months

Arm description

Arm type

Experimental

Investigational medicinal product name

Fidaxomicin

Investigational medicinal product code

OPT-80, ASP2819

Other name

Dificid, Dificlir

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Participants aged 6 months to 23 months were dosed with weight-based doses of open-label fidaxomicin oral suspension 32 mg/kg/day, with a maximum dose of 400 mg/day, divided into 2 doses (every 12 hours), with or without food each day for 10 days.

Fidaxomicin 2-5 Years, 11 Months

Arm description

Arm type

Experimental

Investigational medicinal product name

Fidaxomicin

Investigational medicinal product code

OPT-80, ASP2819

Other name

Dificid, Dificlir

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Participants aged 2-5 years, 11 months were dosed with weight-based doses of open-label fidaxomicin oral suspension 32 mg/kg/day, with a maximum dose of 400 mg/day, divided into 2 doses (every 12 hours), with or without food each day for 10 days.

Fidaxomicin 6-11 Years, 11 Months

Arm description

Arm type

Experimental

Investigational medicinal product name

Fidaxomicin

Investigational medicinal product code

OPT-80, ASP2819

Other name

Dificid, Dificlir

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants aged 6 years to 11 years, 11 months were dosed with open-label fidaxomicin 200 mg tablets by mouth every 12 hours, with or without food, each day for 10 days. Participants aged 6 years to 11 years, 11 months who were unable to swallow tablets received fidaxomicin oral suspension, with a maximum dose of 400 mg/day, divided in 2 doses of 200 mg, with approval by the sponsor on a case-by-case basis and after consultation with the medical monitor.

Fidaxomicin 12-17 Years, 11 Months

Arm description

Arm type

Experimental

Investigational medicinal product name

Fidaxomicin

Investigational medicinal product code

OPT-80, ASP2819

Other name

Dificid, Dificlir

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants aged 12 years to 17 years, 11 months were dosed with open-label fidaxomicin 200 mg tablets by mouth every 12 hours, with or without food, each day for 10 days. Participants aged 12 years to 17 years, 11 months who were unable to swallow tablets received fidaxomicin oral suspension, with a maximum dose of 400 mg/day, divided in 2 doses of 200 mg, with approval by the sponsor on a case-by-case basis and after consultation with the medical monitor.

Number of subjects in period 1	Fidaxomicin 6-23 Months	Fidaxomicin 2-5 Years, 11 Months	Fidaxomicin 6-11 Years, 11 Months	Fidaxomicin 12-17 Years, 11 Months
Started	9	8	9	12
Completed	5	3	7	9
Not completed	4	5	2	3
Consent withdrawn by subject	-	1	-	-
Treatment failure	1	-	-	-
Adverse event	1	2	-	-
Recurrence	2	2	2	3

Baseline characteristics

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Reporting group title

Fidaxomicin 6-23 Months

Reporting group description

Reporting group title

Fidaxomicin 2-5 Years, 11 Months

Reporting group description

Reporting group title

Fidaxomicin 6-11 Years, 11 Months

Reporting group description

Reporting group title

Fidaxomicin 12-17 Years, 11 Months

Reporting group description

Reporting group values	Fidaxomicin 6-23 Months	Fidaxomicin 2-5 Years, 11 Months	Fidaxomicin 6-11 Years, 11 Months	Fidaxomicin 12-17 Years, 11 Months	Total
Number of subjects	9	8	9	12	38
Age categorical
Units: Subjects
Age continuous
Units: months
arithmetic mean (standard deviation)	15.2 ± 3.6	50.5 ± 10.8	116.8 ± 18.7	182.2 ± 19.3	-
Gender categorical
Units: Subjects
Female	6	1	3	6	16
Male	3	7	6	6	22

End points

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Reporting group title

Fidaxomicin 6-23 Months

Reporting group description

Reporting group title

Fidaxomicin 2-5 Years, 11 Months

Reporting group description

Reporting group title

Fidaxomicin 6-11 Years, 11 Months

Reporting group description

Reporting group title

Fidaxomicin 12-17 Years, 11 Months

Reporting group description

Primary: Safety as assessed by incidence of adverse events (AEs), clinical laboratory test results, vital sign measurements, physical examinations, and electrocardiogram (ECG) results

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End point title

Safety as assessed by incidence of adverse events (AEs), clinical laboratory test results, vital sign measurements, physical examinations, and electrocardiogram (ECG) results ^[1]

End point description

An AE is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE may be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product. A serious AE (SAE) is any untoward medical occurrence that at any dose: Was fatal; Was life threatening; Required inpatient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect. A treatment-emergent adverse event (TEAE) is an adverse event with an onset date/time on or after first dose date/time of study drug. The analysis population was the safety analysis set, which included all patients with any evaluable safety data who have received at least one dose of study drug.

End point type

Primary

End point timeframe

From first dose of study drug to 30 days after last dose of study drug (up to 41 days)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any endpoints due to the simple design and purposes of the study.

End point values	Fidaxomicin 6-23 Months	Fidaxomicin 2-5 Years, 11 Months	Fidaxomicin 6-11 Years, 11 Months	Fidaxomicin 12-17 Years, 11 Months
Number of subjects analysed	9	8	9	12
Units: participants
With any TEAE	7	7	6	8
With any severe TEAE	1	1	0	1
With any treatment-related TEAE	0	3	2	1
With any SAE	4	3	1	1
With an AE leading to discontinuation	0	3	0	0
With an AE leading to death	1	0	0	0

No statistical analyses for this end point

Primary: Pharmacokinetic plasma concentration levels of fidaxomicin

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End point title

Pharmacokinetic plasma concentration levels of fidaxomicin ^[2]

End point description

The analysis population was the plasma pharmacokinetic (PK) analysis set which included all dosed participants with evaluable plasma PK data, and excluded concentrations for which a problem occurred during sampling or laboratory analysis that invalidates the concentration measurements.

End point type

Primary

End point timeframe

Days 5-10

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any endpoints due to the simple design and purposes of the study.

End point values	Fidaxomicin 6-23 Months	Fidaxomicin 2-5 Years, 11 Months	Fidaxomicin 6-11 Years, 11 Months	Fidaxomicin 12-17 Years, 11 Months
Number of subjects analysed	8 ^[3]	7 ^[4]	9 ^[5]	12 ^[6]
Units: ng/mL
arithmetic mean (standard deviation)
Pre-dose [N=7,5,9,11]	13.171 ± 23.494	9.236 ± 3.546	10.081 ± 6.437	7.836 ± 8.638
1-2 hours postdose [N=8,5,9,12]	13.364 ± 21.03	16.618 ± 10.9	12.363 ± 11.704	8.874 ± 6.604
3-5 hours postdose [N=8,5,8,11]	15.217 ± 29.31	14.606 ± 5.411	15.59 ± 10.059	9.83 ± 6.083

Notes
[3] - N = Participants with plasma concentrations above the lower limit of quantification.
[4] - N = Participants with plasma concentrations above the lower limit of quantification.
[5] - N = Participants with plasma concentrations above the lower limit of quantification.
[6] - N = Participants with plasma concentrations above the lower limit of quantification.

No statistical analyses for this end point

Primary: Pharmacokinetic plasma concentration levels of fidaxomicin metabolite OP-1118

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End point title

Pharmacokinetic plasma concentration levels of fidaxomicin metabolite OP-1118 ^[7]

End point description

The analysis population was the PK analysis set.

End point type

Primary

End point timeframe

Days 5-10

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any endpoints due to the simple design and purposes of the study.

End point values	Fidaxomicin 6-23 Months	Fidaxomicin 2-5 Years, 11 Months	Fidaxomicin 6-11 Years, 11 Months	Fidaxomicin 12-17 Years, 11 Months
Number of subjects analysed	8 ^[8]	7 ^[9]	9 ^[10]	12 ^[11]
Units: ng/mL
arithmetic mean (standard deviation)
Pre-dose [N=7,6,9,12]	133.376 ± 316.127	30.624 ± 27.326	38.838 ± 36.677	22.312 ± 22.035
1-2 hours postdose [N=8,4,9,12]	130.235 ± 323.276	51.725 ± 31.296	47.321 ± 44.274	27.476 ± 18.101
3-5 hours postdose [N=8,4,9,12]	121.946 ± 307.181	45.825 ± 20.034	53.341 ± 62.232	28.465 ± 20.645

Notes
[8] - N = Participants with plasma concentrations above the lower limit of quantification.
[9] - N = Participants with plasma concentrations above the lower limit of quantification.
[10] - N = Participants with plasma concentrations above the lower limit of quantification.
[11] - N = Participants with plasma concentrations above the lower limit of quantification.

No statistical analyses for this end point

Primary: Pharmacokinetic fecal concentration levels of fidaxomicin

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End point title

Pharmacokinetic fecal concentration levels of fidaxomicin ^[12]

End point description

The analysis population was the fecal PK analysis set which included all dosed participants with evaluable fecal data, and excluded concentrations for which a problem occurred during collection or laboratory analysis that invalidates the concentration measurements.

End point type

Primary

End point timeframe

End of therapy (Day 10)

Notes
[12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any endpoints due to the simple design and purposes of the study.

End point values	Fidaxomicin 6-23 Months	Fidaxomicin 2-5 Years, 11 Months	Fidaxomicin 6-11 Years, 11 Months	Fidaxomicin 12-17 Years, 11 Months
Number of subjects analysed	8 ^[13]	4 ^[14]	9 ^[15]	9 ^[16]
Units: μg/g
arithmetic mean (standard deviation)
Postdose	5406.88 ± 3859.37	1404.75 ± 1312.93	2980.44 ± 1800.64	2348.89 ± 1239.11

Notes
[13] - Participants with fecal concentrations above the lower limit of quantification.
[14] - Participants with fecal concentrations above the lower limit of quantification.
[15] - Participants with fecal concentrations above the lower limit of quantification.
[16] - Participants with fecal concentrations above the lower limit of quantification.

No statistical analyses for this end point

Primary: Pharmacokinetic fecal concentration levels of fidaxomicin metabolite OP-1118

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End point title

Pharmacokinetic fecal concentration levels of fidaxomicin metabolite OP-1118 ^[17]

End point description

The analysis population was the fecal PK analysis set.

End point type

Primary

End point timeframe

End of therapy (Day 10)

Notes
[17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any endpoints due to the simple design and purposes of the study.

End point values	Fidaxomicin 6-23 Months	Fidaxomicin 2-5 Years, 11 Months	Fidaxomicin 6-11 Years, 11 Months	Fidaxomicin 12-17 Years, 11 Months
Number of subjects analysed	7 ^[18]	3 ^[19]	9 ^[20]	9 ^[21]
Units: μg/g
arithmetic mean (standard deviation)
Postdose	758.83 ± 548.67	250.67 ± 100.27	1147.22 ± 817.16	871.67 ± 368.64

Notes
[18] - Participants with fecal concentrations above the lower limit of quantification.
[19] - Participants with fecal concentrations above the lower limit of quantification.
[20] - Participants with fecal concentrations above the lower limit of quantification.
[21] - Participants with fecal concentrations above the lower limit of quantification.

No statistical analyses for this end point

Secondary: Percentage of participants with clinical response (cure)

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End point title

Percentage of participants with clinical response (cure)

End point description

Positive clinical response (cure) was determined as follows: 6 to 23 months: who no longer had watery diarrhea for 2 consecutive days during treatment, who remained well before the time of study drug discontinuation, and who did not require further CDAD therapy within 2 days after completion of study drug were considered to have a positive clinical response; 2 years to 17 years, 11 months: who had improvement in the number and character of bowel movements as determined by 3 or fewer unformed bowel movements for 2 consecutive days during treatment, who remained well before the time of study drug discontinuation, and who did not require further CDAD therapy within 2 days after completion of study drug were considered to have a positive clinical response. The analysis population was the modified intent-to-treat (mITT) analysis set which included all participants with CDAD confirmed by a positive toxin assay within 24 hours prior to enrollment who received at least one dose of study drug.

End point type

Secondary

End point timeframe

End of therapy (Day 10)

End point values	Fidaxomicin 6-23 Months	Fidaxomicin 2-5 Years, 11 Months	Fidaxomicin 6-11 Years, 11 Months	Fidaxomicin 12-17 Years, 11 Months
Number of subjects analysed	9	8	9	12
Units: percentage of participants
number (confidence interval 95%)	88.9 (68.4 to 100)	75 (45 to 100)	100 (100 to 100)	100 (100 to 100)

No statistical analyses for this end point

Secondary: Percentage of participants with recurrence of CDAD

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End point title

Percentage of participants with recurrence of CDAD

End point description

Recurrence was defined as the the re-establishment of diarrhea after a positive clinical response, where the number of unformed bowel movements (UBMs) was greater than that noted on the last day of study drug and toxin A and/or B was present, and the investigator considered that retreatment of CDAD was necessary. Only participants who achieved a positive clinical response by end of therapy visit were included. Participants who withdrew from the study during the follow-up period were considered to have a recurrence. The analysis population was the mITT analysis set.

End point type

Secondary

End point timeframe

From end of therapy to 28 days post-treatment

End point values	Fidaxomicin 6-23 Months	Fidaxomicin 2-5 Years, 11 Months	Fidaxomicin 6-11 Years, 11 Months	Fidaxomicin 12-17 Years, 11 Months
Number of subjects analysed	8	6	9	12
Units: percentage of participants
number (confidence interval 95%)	25 (0 to 55)	33.3 (0 to 71.1)	22.4 (0 to 49.4)	33.3 (6.7 to 60)

No statistical analyses for this end point

Secondary: Time to recurrence of CDAD

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End point title

Time to recurrence of CDAD

End point description

Time to recurrence of CDAD was defined as the time in days from date of cure to the date of recurrence. Only participants who achieved a positive clinical response by end of therapy visit were included. The survival function for time to recurrence (in days) will be estimated using the Kaplan-Meier method using LIFETEST procedure in SAS. Participants who never recurred during the follow-up period were censored at 30 days after last dose. The analysis population was the mITT analysis set. Confidence Interval (CI) limit that could not be calculated is denoted as "99999" as applicable.

End point type

Secondary

End point timeframe

From end of therapy to 28 days post-treatment

End point values	Fidaxomicin 6-23 Months	Fidaxomicin 2-5 Years, 11 Months	Fidaxomicin 6-11 Years, 11 Months	Fidaxomicin 12-17 Years, 11 Months
Number of subjects analysed	2 ^[22]	2 ^[23]	2 ^[24]	4 ^[25]
Units: days
number (confidence interval 95%)
10th percentile	5 (5 to 99999)	9 (9 to 99999)	11 (11 to 99999)	22 (19 to 30)
20th percentile	7 (5 to 99999)	18 (9 to 99999)	27 (11 to 99999)	23 (19 to 99999)

Notes
[22] - Participants with recurrence.
[23] - Participants with recurrence.
[24] - Participants with recurrence.
[25] - Participants with recurrence.

No statistical analyses for this end point

Secondary: Percentage of participants with sustained clinical response

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End point title

Percentage of participants with sustained clinical response

End point description

Sustained clinical response was defined as positive clinical response at the end of treatment without proven or suspected CDAD recurrence through 28 days post treatment. Only participants who achieved a positive clinical response by end of therapy visit were included.The analysis population was the mITT analysis set.

End point type

Secondary

End point timeframe

From end of therapy to 28 days post-treatment

End point values	Fidaxomicin 6-23 Months	Fidaxomicin 2-5 Years, 11 Months	Fidaxomicin 6-11 Years, 11 Months	Fidaxomicin 12-17 Years, 11 Months
Number of subjects analysed	9	8	9	12
Units: percentage of participants
number (confidence interval 95%)	66.7 (35.9 to 97.5)	50 (15.4 to 84.7)	77.8 (50.6 to 100)	66.7 (40 to 93.3)

No statistical analyses for this end point

Secondary: Time to resolution of diarrhea

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End point title

Time to resolution of diarrhea

End point description

Time to resolution of diarrhea was defined as the time elapsed (in hours rounded up from minutes ≥30) from the start of treatment (time of first dose of study drug) to resolution of diarrhea (time of the last UBM the day before the first of 2 consecutive days of ≤3 UBMs that were sustained through the end of therapy). The survival function for time to recurrence (in days) was estimated using the Kaplan-Meier method using LIFETEST procedure in SAS. Participants were censored at time of discontinuation, except for those subjects who completed End of Therapy and did not have resolution of diarrhea were censored at 240 hours. The analysis population was the mITT analysis set. Confidence Interval (CI) limit that could not be calculated is denoted as "99999" as applicable.

End point type

Secondary

End point timeframe

From first dose of study drug to last dose of study drug (up to Day 10)

End point values	Fidaxomicin 6-23 Months	Fidaxomicin 2-5 Years, 11 Months	Fidaxomicin 6-11 Years, 11 Months	Fidaxomicin 12-17 Years, 11 Months
Number of subjects analysed	8 ^[26]	6 ^[27]	9 ^[28]	12 ^[29]
Units: hours
number (confidence interval 95%)
25th percentile	116 (36 to 121)	0 (0 to 36)	0 (0 to 49)	0 (0 to 13)
50th percentile	121 (36 to 240)	18 (0 to 99999)	49 (0 to 99)	22 (0 to 127)
75th percentile	140 (119 to 240)	46 (0 to 99999)	75 (25 to 177)	113 (13 to 147)

Notes
[26] - Participants with resolved diarrhea.
[27] - Participants with resolved diarrhea.
[28] - Participants with resolved diarrhea.
[29] - Participants with resolved diarrhea.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From first dose of study drug to 30 days after last dose of study drug

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

15.0

Reporting group title

Fidaxomicin 6-23 Months

Reporting group description

Reporting group title

Fidaxomicin 6-11 Years, 11 Months

Reporting group description

Reporting group title

Fidaxomicin 12-17 Years, 11 Months

Reporting group description

Reporting group title

Fidaxomicin 2-5 Years, 11 Months

Reporting group description

Serious adverse events	Fidaxomicin 6-23 Months	Fidaxomicin 6-11 Years, 11 Months	Fidaxomicin 12-17 Years, 11 Months	Fidaxomicin 2-5 Years, 11 Months
Total subjects affected by serious adverse events
subjects affected / exposed	4 / 9 (44.44%)	1 / 9 (11.11%)	1 / 12 (8.33%)	3 / 8 (37.50%)
number of deaths (all causes)	1	0	0	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Gastrostomy Failure
subjects affected / exposed	1 / 9 (11.11%)	0 / 9 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Febrile Neutropenia
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Haematemesis
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	1 / 8 (12.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
subjects affected / exposed	1 / 9 (11.11%)	0 / 9 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Infections and infestations
Adenovirus Infection
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Clostridial Infection
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Clostridium Difficile Colitis
subjects affected / exposed	2 / 9 (22.22%)	1 / 9 (11.11%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Septic Shock
subjects affected / exposed	1 / 9 (11.11%)	0 / 9 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Fidaxomicin 6-23 Months	Fidaxomicin 6-11 Years, 11 Months	Fidaxomicin 12-17 Years, 11 Months	Fidaxomicin 2-5 Years, 11 Months
Total subjects affected by non serious adverse events
subjects affected / exposed	7 / 9 (77.78%)	6 / 9 (66.67%)	8 / 12 (66.67%)	7 / 8 (87.50%)
Vascular disorders
Hypertension
subjects affected / exposed	1 / 9 (11.11%)	0 / 9 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)
occurrences all number	1	0	1	0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	0 / 9 (0.00%)	1 / 9 (11.11%)	1 / 12 (8.33%)	0 / 8 (0.00%)
occurrences all number	0	1	1	0
Pyrexia
subjects affected / exposed	3 / 9 (33.33%)	0 / 9 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)
occurrences all number	3	0	3	0
Immune system disorders
Graft versus host disease
subjects affected / exposed	0 / 9 (0.00%)	1 / 9 (11.11%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	0	1	0	0
Respiratory, thoracic and mediastinal disorders
Epistaxis
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)
occurrences all number	0	0	1	0
Nasal congestion
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)
occurrences all number	0	0	1	0
Nasal dryness
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)
occurrences all number	0	0	1	0
Oropharyngeal pain
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)
occurrences all number	0	0	1	0
Respiratory distress
subjects affected / exposed	1 / 9 (11.11%)	0 / 9 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	1	0	0	0
Rhinorrhoea
subjects affected / exposed	1 / 9 (11.11%)	0 / 9 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	1	0	0	0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 9 (0.00%)	1 / 9 (11.11%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	0	1	0	0
Aspartate aminotransferase increased
subjects affected / exposed	0 / 9 (0.00%)	1 / 9 (11.11%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	0	1	0	0
Blood glucose increased
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	0	1
Blood magnesium increased
subjects affected / exposed	1 / 9 (11.11%)	0 / 9 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	1	0	0	0
Blood pressure increased
subjects affected / exposed	1 / 9 (11.11%)	0 / 9 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	1	0	0	0
Blood uric acid increased
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	0	1
Body temperature increased
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	0	1
Gamma-glutamyltransferase increased
subjects affected / exposed	0 / 9 (0.00%)	1 / 9 (11.11%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	0	1	0	0
Haemoglobin increased
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	0	1
Urine output decreased
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)
occurrences all number	0	0	1	0
Urine output increased
subjects affected / exposed	0 / 9 (0.00%)	1 / 9 (11.11%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	0	1	0	0
Injury, poisoning and procedural complications
Laceration
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	0	1
Ligament sprain
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)
occurrences all number	0	0	1	0
Procedural complication
subjects affected / exposed	1 / 9 (11.11%)	0 / 9 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	1	0	0	0
Cardiac disorders
Tachycardia
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	0	1
Nervous system disorders
Headache
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	2 / 12 (16.67%)	0 / 8 (0.00%)
occurrences all number	0	0	3	0
Eye disorders
Eye discharge
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	0	1
Eye pain
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)
occurrences all number	0	0	1	0
Gastrointestinal disorders
Abdominal pain upper
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	2 / 8 (25.00%)
occurrences all number	0	0	1	2
Constipation
subjects affected / exposed	0 / 9 (0.00%)	1 / 9 (11.11%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	1	0	1
Diarrhoea
subjects affected / exposed	0 / 9 (0.00%)	2 / 9 (22.22%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	0	2	0	0
Nausea
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	2 / 8 (25.00%)
occurrences all number	0	0	0	2
Oesophagitis
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	1 / 8 (12.50%)
occurrences all number	0	0	1	1
Vomiting
subjects affected / exposed	0 / 9 (0.00%)	1 / 9 (11.11%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	3	0	3
Abdominal pain
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	0	1
Dyspepsia
subjects affected / exposed	0 / 9 (0.00%)	1 / 9 (11.11%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	0	1	0	0
Flatulence
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	0	1
Gastrointestinal inflammation
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)
occurrences all number	0	0	4	0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	0	1
Gingival inflammation
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	0	1
Proctalgia
subjects affected / exposed	1 / 9 (11.11%)	0 / 9 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	1	0	0	0
Stomatitis
subjects affected / exposed	1 / 9 (11.11%)	0 / 9 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	1	0	0	0
Hepatobiliary disorders
Hepatosplenomegaly
subjects affected / exposed	1 / 9 (11.11%)	0 / 9 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	1	0	0	0
Skin and subcutaneous tissue disorders
Urticaria
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	1 / 8 (12.50%)
occurrences all number	0	0	1	1
Dermatitis diaper
subjects affected / exposed	1 / 9 (11.11%)	0 / 9 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	1	0	0	0
Erythema
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)
occurrences all number	0	0	1	0
Papule
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)
occurrences all number	0	0	1	0
Pruritus
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)
occurrences all number	0	0	1	0
Rash
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)
occurrences all number	0	0	1	0
Renal and urinary disorders
Enuresis
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)
occurrences all number	0	0	1	0
Infections and infestations
Nasopharyngitis
subjects affected / exposed	2 / 9 (22.22%)	0 / 9 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	2	0	0	0
Candidiasis
subjects affected / exposed	1 / 9 (11.11%)	0 / 9 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	1	0	0	0
Enterobacter bacteraemia
subjects affected / exposed	1 / 9 (11.11%)	0 / 9 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	1	0	0	0
Rash pustular
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)
occurrences all number	0	0	1	0
Sinusitis
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)
occurrences all number	0	0	1	0
Upper respiratory tract infection
subjects affected / exposed	1 / 9 (11.11%)	0 / 9 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	1	0	0	0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	2 / 8 (25.00%)
occurrences all number	0	0	0	2
Hyperkalaemia
subjects affected / exposed	1 / 9 (11.11%)	0 / 9 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	1	0	0	0
Hypocalcaemia
subjects affected / exposed	1 / 9 (11.11%)	0 / 9 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)
occurrences all number	1	0	0	0
Hypokalaemia
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	0	1
Hypomagnesaemia
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	0	1
Hypophagia
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	0	1
Metabolic acidosis
subjects affected / exposed	0 / 9 (0.00%)	0 / 9 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	0	1

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Were there any global substantial amendments to the protocol? Yes

25 Jan 2012

Major changes to the conduct of the study are summarized: (1) Revised the timing of the CDAD signs and symptoms evaluation to address redundancy with this assessment and the participant/legal guardian interview (CDAD status); (2) Revised the timing of the investigator’s determination of clinical response as was noted in the schedule of events; (3) Revised AE language for clarity and consistency.

04 Apr 2012

Major changes to the conduct of the study are summarized: (1) Clarified the age limit to 17 years, 11 months; (2) Changed “mother or legal guardian” to “parent or legal guardian”; (3) Updated sponsor contact information; (4) Updated study design to include interviews of the participant/legal guardian on CDAD status to be conducted daily and 2 to 3 days after the last dose of study medication and then weekly through 28 days after treatment; (5) Study assessments were updated to include fecal sample collection at the end of therapy visit to determine concentrations of fidaxomicin and its main metabolite, OP-1118; (6) Clarified that dose preparations and administration based on the participant’s weight were calculated at enrollment and remained consistent throughout the treatment period; (7) Updated the facsimile number for AE reports and pregnancy data collection form to be sent; (8) Removed efficacy from data that was to be reviewed by the Safety Moitorig Committee (SMC).

13 Jun 2012

Major changes to the conduct of the study are summarized: (1) Clarified that dose preparation and administration could not be changed during the course of the 10-day treatment; (2) Updated study evaluations on clinical laboratory tests and pregnancy tests; (3) Updated recording and reporting of AEs.

11 Oct 2012

Major changes to the conduct of the study are summarized: (1) Added “Informed consent/assent was provided” as an inclusion criterion; (2) Removed exclusion of participants with >24 hours of prior treatment with oral vancomycin and/or metronidazole; (3) Restricted the list of excluded P-glycoprotein inhibitors to cyclosporine, itraconazole and ketoconazole, erythromycin, azithromycin, and clarithromycin, verapamil, dronedarone and amiodarone, captopril, carvedilol, conivaptan, diltiazem, felodipine, lopinavir and ritonavir, quercetin, quinidine, and ranolazine; (4) Updated exclusion criteria to include: (a) Need for concurrent use of oral vancomycin, metronidazole or any other effective treatments for CDAD during therapy with fidaxomicin, (b) pregnant or breast-feeding an infant, (c) Fulminant colitis, (d) a history of inflammatory bowel disease (ulcerative colitis or Crohn’s disease), (e) need for concurrent use of the following P-glycoprotein inhibitors during therapy with fidaxomicin: cyclosporine, itraconazole, and ketoconazole; erythromycin, azithromycin, and clarithromycin; verapamil, dronedarone, and amiodarone; captopril, carvedilol, conivaptan, diltiazem, felodipine, lopinavir, and ritonavir; quercetin, quinidine, and ranolazine; topical ointments were not excluded, nor was administration of any P-glycoprotein inhibitors during the follow-up period, (f) updated concomitant therapy for consistency with exclusion criteria for P-glycoprotein inhibitors, (g) updated the protocol to Dificid package insert dated October 2012.

12 Dec 2013

Major changes to the conduct of the study are summarized: (1) Added that Optimer is now a Cubist company and updated signatory and contact personnel; (2) Updated sample size to at least 32 and up to 35 evaluable subjects and stipulated that with Amendment 5, further enrollment should only consist of subjects in stratum 2 (2 years to 5 years, 11 months); (3) Updated exposure margin in dogs to 117×; (4) Clarified that to be included in the plasma PK population, participants must have had 1 predose and at least 1 of the postdose PK blood samples collected at the PK visit (within the time of maximal concentration window, 1–5 hours after dosing); (5) Updated dose preparation and administration to allow a subject who could not swallow a tablet to receive a crushed tablet if the oral formulation was not available and if the subject met weight requirements to receive the full adult dose of 400 mg/day. Instructions for crushing the tablet were provided in the appendix of the amendment; the following instruction was added: If the subject was not of sufficient weight (12.5 kg) to receive the full adult dose and the oral suspension was no longer available, the subject should not have been enrolled; (6) Clarified that pregnancy tests were only to be conducted in females of childbearing potential; (7) Updated medical monitor and associated contact information; (8) Updated Difficid package insert to current version (March 2013); (9) Added an appendix in protocol, crushed tablet preparation.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
A Phase 2A, Multi-Center, Open-Label, Uncontrolled Study to Determine the Safety, Tolerability, and Pharmacokinetics of fidaxomicin Oral Suspension or Tablets in Pediatric Subjects With Clostridium difficile-associated Diarrhea

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Safety as assessed by incidence of adverse events (AEs), clinical laboratory test results, vital sign measurements, physical examinations, and electrocardiogram (ECG) results

Primary: Safety as assessed by incidence of adverse events (AEs), clinical laboratory test results, vital sign measurements, physical examinations, and electrocardiogram (ECG) results

Primary: Pharmacokinetic plasma concentration levels of fidaxomicin

Primary: Pharmacokinetic plasma concentration levels of fidaxomicin

Primary: Pharmacokinetic plasma concentration levels of fidaxomicin metabolite OP-1118

Primary: Pharmacokinetic plasma concentration levels of fidaxomicin metabolite OP-1118

Primary: Pharmacokinetic fecal concentration levels of fidaxomicin

Primary: Pharmacokinetic fecal concentration levels of fidaxomicin

Primary: Pharmacokinetic fecal concentration levels of fidaxomicin metabolite OP-1118

Primary: Pharmacokinetic fecal concentration levels of fidaxomicin metabolite OP-1118

Secondary: Percentage of participants with clinical response (cure)

Secondary: Percentage of participants with clinical response (cure)

Secondary: Percentage of participants with recurrence of CDAD

Secondary: Percentage of participants with recurrence of CDAD

Secondary: Time to recurrence of CDAD

Secondary: Time to recurrence of CDAD

Secondary: Percentage of participants with sustained clinical response

Secondary: Percentage of participants with sustained clinical response

Secondary: Time to resolution of diarrhea

Secondary: Time to resolution of diarrhea

Adverse events

Adverse events

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Substantial protocol amendments (globally)

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Clinical trials

Clinical Trial Results: A Phase 2A, Multi-Center, Open-Label, Uncontrolled Study to Determine the Safety, Tolerability, and Pharmacokinetics of fidaxomicin Oral Suspension or Tablets in Pediatric Subjects With Clostridium difficile-associated Diarrhea

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Safety as assessed by incidence of adverse events (AEs), clinical laboratory test results, vital sign measurements, physical examinations, and electrocardiogram (ECG) results

Primary: Safety as assessed by incidence of adverse events (AEs), clinical laboratory test results, vital sign measurements, physical examinations, and electrocardiogram (ECG) results

Primary: Pharmacokinetic plasma concentration levels of fidaxomicin

Primary: Pharmacokinetic plasma concentration levels of fidaxomicin

Primary: Pharmacokinetic plasma concentration levels of fidaxomicin metabolite OP-1118

Primary: Pharmacokinetic plasma concentration levels of fidaxomicin metabolite OP-1118

Primary: Pharmacokinetic fecal concentration levels of fidaxomicin

Primary: Pharmacokinetic fecal concentration levels of fidaxomicin

Primary: Pharmacokinetic fecal concentration levels of fidaxomicin metabolite OP-1118

Primary: Pharmacokinetic fecal concentration levels of fidaxomicin metabolite OP-1118

Secondary: Percentage of participants with clinical response (cure)

Secondary: Percentage of participants with clinical response (cure)

Secondary: Percentage of participants with recurrence of CDAD

Secondary: Percentage of participants with recurrence of CDAD

Secondary: Time to recurrence of CDAD

Secondary: Time to recurrence of CDAD

Secondary: Percentage of participants with sustained clinical response

Secondary: Percentage of participants with sustained clinical response

Secondary: Time to resolution of diarrhea

Secondary: Time to resolution of diarrhea

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 2A, Multi-Center, Open-Label, Uncontrolled Study to Determine the Safety, Tolerability, and Pharmacokinetics of fidaxomicin Oral Suspension or Tablets in Pediatric Subjects With Clostridium difficile-associated Diarrhea