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Clinical Trial Results:
An Evaluation of the Pharmacokinetic Profile and Safety of a Single Dose of Daptomycin in Pediatric Subjects Aged 3 Months to Twenty-Four Months Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Bacterial Infection Including Peri-Operative Prophylactic Use of Antibiotics

Summary
EudraCT number	2015-002779-64
Trial protocol	Outside EU/EEA
Global end of trial date	20 Mar 2012

Results information
Results version number	v2(current)
This version publication date	30 Apr 2016
First version publication date	05 Aug 2015
Other versions	v1
Version creation reason

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

3009-018

ISRCTN number

US NCT number

NCT01019395

WHO universal trial number (UTN)

Sponsor organisation name

Cubist Pharmaceuticals

Sponsor organisation address

65 Hayden Avenue, Lexington, United States, 02421

Public contact

Study Director, Cubist Pharmaceuticals, +1 781-860-8660,

Scientific contact

Study Director, Cubist Pharmaceuticals, +1 781-860-8660,

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

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

30 Aug 2012

Is this the analysis of the primary completion data?

Yes

Primary completion date

20 Mar 2012

Global end of trial reached?

Yes

Global end of trial date

20 Mar 2012

Was the trial ended prematurely?

Main objective of the trial

The primary objective of this study was to evaluate single dose pharmacokinetics (PK) data of intravenous (i.v.) daptomycin administered at 4 milligrams per kilogram (mg/kg) or 6 mg/kg as a 30 minute infusion in pediatric subjects aged 3 to 24 months, inclusive, with proven or suspected bacterial infection who were receiving standard antibiotic therapy, including subjects that were receiving prophylactic antibiotics peri-operatively.

Protection of trial subjects

This open-label study did not employ any blinding methods. Screening assessments included medical and medication history, demographics, physical examination, vital signs, a brief neurology examination, electrocardiogram, clinical laboratory tests (hematology, chemistry, urinalysis, serum creatine kinase, and serum creatinine). Study subjects were monitored for adverse events. The study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practices (GCP), Food and Drug Administration (FDA) Code of Federal Regulations (CFR) 312.120, and applicable local regulatory requirements. The protocol, informed consent form (ICF), and all other written documents provided to the parent (or appropriate legal representative) were reviewed and approved by an independent Institutional Review Board (IRB) at each site before the study began. In addition, this study enrolled in a stepwise fashion. It began with age group 1 and after review of PK and safety data, age group 2 was enrolled, and continued in this manner.

Background therapy

Evidence for comparator

This was a non-comparative study.

Actual start date of recruitment

13 Jan 2010

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 32

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

Written parental (or appropriate legal representative) informed consent was obtained prior to the initiation of any of the assessments/procedures required by the protocol, and subjects met all of the inclusion and none of the exclusion criteria prior to enrollment in this study. Eligible subjects received open-label study drug treatment.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Daptomycin 6 mg/kg: Ages 13 months to 24 months

Arm description

Subjects aged 13 months to 24 months inclusive received a single dose of i.v. daptomycin 6 mg/kg over a duration of 30 minutes.

Arm type

Experimental

Investigational medicinal product name

Daptomycin

Investigational medicinal product code

Other name

Cubicin®

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

All subjects received a single-dose of daptomycin 6 mg/kg dissolved in 0.9% sodium chloride for injection. Daptomycin was administered i.v. over 30 minutes. The dosing volume was 25 millilitres (mL) and the infusion rate was 0.83 mL per minute for the 30 minute infusion.

Daptomycin 4 mg/kg: Ages 7 months to 12 months

Arm description

Subjects aged 7 months to 12 months inclusive received a single dose of i.v. daptomycin 4 mg/kg over a duration of 30 minutes.

Arm type

Experimental

Investigational medicinal product name

Daptomycin

Investigational medicinal product code

Other name

Cubicin®

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

All subjects received a single-dose of daptomycin 4 mg/kg dissolved in 0.9% sodium chloride for injection. Daptomycin was administered i.v. over 30 minutes. The dosing volume was 25 mL and the infusion rate was 0.83 mL per minute for the 30 minute infusion.

Daptomycin 4 mg/kg: Ages 3 months to 6 months

Arm description

Subjects aged 3 months to 6 months inclusive received a single dose of i.v. daptomycin 4 mg/kg over a duration of 30 minutes.

Arm type

Experimental

Investigational medicinal product name

Daptomycin

Investigational medicinal product code

Other name

Cubicin®

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Number of subjects in period 1	Daptomycin 6 mg/kg: Ages 13 months to 24 months	Daptomycin 4 mg/kg: Ages 7 months to 12 months	Daptomycin 4 mg/kg: Ages 3 months to 6 months
Started	13	9	10
Subjects that received a complete dose	7	8	9
Completed	7	7	9
Not completed	6	2	1
Not Specified	4	1	-
Parent's Decision	2	1	1

Baseline characteristics

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Reporting group title

Daptomycin 6 mg/kg: Ages 13 months to 24 months

Reporting group description

Subjects aged 13 months to 24 months inclusive received a single dose of i.v. daptomycin 6 mg/kg over a duration of 30 minutes.

Reporting group title

Daptomycin 4 mg/kg: Ages 7 months to 12 months

Reporting group description

Subjects aged 7 months to 12 months inclusive received a single dose of i.v. daptomycin 4 mg/kg over a duration of 30 minutes.

Reporting group title

Daptomycin 4 mg/kg: Ages 3 months to 6 months

Reporting group description

Subjects aged 3 months to 6 months inclusive received a single dose of i.v. daptomycin 4 mg/kg over a duration of 30 minutes.

Reporting group values	Daptomycin 6 mg/kg: Ages 13 months to 24 months	Daptomycin 4 mg/kg: Ages 7 months to 12 months	Daptomycin 4 mg/kg: Ages 3 months to 6 months	Total
Number of subjects	13	9	10	32
Age categorical
Age of all enrolled subjects and all subjects that received a complete dose of study drug.
Units: Subjects
Infants and toddlers (28 days-23 months)	13	9	10	32
Age continuous
Age of all subjects that received a complete dose of study drug presented. Age of all enrolled subjects was not calculated and values of "0" were presented.
Units: months
arithmetic mean (standard deviation)	0 ( 0 )	0 ( 0 )	0 ( 0 )	-
Gender categorical
Gender of all subjects that received a complete dose of study drug is presented. Gender was not known for 8 subjects in the overall study baseline population. These subjects were counted in the male catagory for the overall baseline population. They are not included in the subject analysis populations.
Units: Subjects
Female	3	4	8	15
Male	10	5	2	17

Subject analysis set title

Daptomycin 6 mg/kg: Ages 13 to 24 months - Safety Population

Subject analysis set type

Safety analysis

Subject analysis set description

Subjects aged 13 months to 24 months inclusive received a single dose of i.v. daptomycin 6 mg/kg over a duration of 30 minutes.

Subject analysis set title

Daptomycin 4 mg/kg: Ages 7 to 12 months - Safety Population

Subject analysis set type

Safety analysis

Subject analysis set description

Subjects aged 7 months to 12 months inclusive received a single dose of i.v. daptomycin 4 mg/kg over a duration of 30 minutes.

Subject analysis set title

Daptomycin 4 mg/kg: Ages 3 to 6 months - Safety Population

Subject analysis set type

Safety analysis

Subject analysis set description

Subjects aged 3 months to 6 months inclusive received a single dose of i.v. daptomycin 4 mg/kg over a duration of 30 minutes.

Subject analysis sets values	Daptomycin 6 mg/kg: Ages 13 to 24 months - Safety Population	Daptomycin 4 mg/kg: Ages 7 to 12 months - Safety Population	Daptomycin 4 mg/kg: Ages 3 to 6 months - Safety Population
Number of subjects	7	8	9
Age categorical
Age of all enrolled subjects and all subjects that received a complete dose of study drug.
Units: Subjects
Infants and toddlers (28 days-23 months)	7	8	9
Age continuous
Age of all subjects that received a complete dose of study drug presented. Age of all enrolled subjects was not calculated and values of "0" were presented.
Units: months
arithmetic mean (standard deviation)	19.46 ( 1.459 )	9.8 ( 1.708 )	4.79 ( 1.374 )
Gender categorical
Gender of all subjects that received a complete dose of study drug is presented. Gender was not known for 8 subjects in the overall study baseline population. These subjects were counted in the male catagory for the overall baseline population. They are not included in the subject analysis populations.
Units: Subjects
Female	3	4	8
Male	4	4	1

End points

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Reporting group title

Daptomycin 6 mg/kg: Ages 13 months to 24 months

Reporting group description

Subjects aged 13 months to 24 months inclusive received a single dose of i.v. daptomycin 6 mg/kg over a duration of 30 minutes.

Reporting group title

Daptomycin 4 mg/kg: Ages 7 months to 12 months

Reporting group description

Subjects aged 7 months to 12 months inclusive received a single dose of i.v. daptomycin 4 mg/kg over a duration of 30 minutes.

Reporting group title

Daptomycin 4 mg/kg: Ages 3 months to 6 months

Reporting group description

Subjects aged 3 months to 6 months inclusive received a single dose of i.v. daptomycin 4 mg/kg over a duration of 30 minutes.

Subject analysis set title

Daptomycin 6 mg/kg: Ages 13 to 24 months - Safety Population

Subject analysis set type

Safety analysis

Subject analysis set description

Subjects aged 13 months to 24 months inclusive received a single dose of i.v. daptomycin 6 mg/kg over a duration of 30 minutes.

Subject analysis set title

Daptomycin 4 mg/kg: Ages 7 to 12 months - Safety Population

Subject analysis set type

Safety analysis

Subject analysis set description

Subjects aged 7 months to 12 months inclusive received a single dose of i.v. daptomycin 4 mg/kg over a duration of 30 minutes.

Subject analysis set title

Daptomycin 4 mg/kg: Ages 3 to 6 months - Safety Population

Subject analysis set type

Safety analysis

Subject analysis set description

Subjects aged 3 months to 6 months inclusive received a single dose of i.v. daptomycin 4 mg/kg over a duration of 30 minutes.

Primary: Pharmacokinetics of daptomycin: Maximum plasma concentration

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End point title

Pharmacokinetics of daptomycin: Maximum plasma concentration ^[1]

End point description

Maximum plasma concentration (Cmax) presented in micrograms per milliliter over the entire sampling phase directly obtained from the experimental plasma concentration time data, without interpolation.

End point type

Primary

End point timeframe

Pre-dose, at end of infusion, and 1 hours, 2 hours, 6 hours, and 12 hours after the start of infusion.

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 a Phase 1, single dose, open-label, non-comparative study and therefore only descriptive analyses were performed. No statistical tests were performed.

End point values	Daptomycin 6 mg/kg: Ages 13 months to 24 months	Daptomycin 4 mg/kg: Ages 7 months to 12 months	Daptomycin 4 mg/kg: Ages 3 months to 6 months
Number of subjects analysed	5	7	7
Units: micrograms per millilitre
arithmetic mean (standard deviation)	67 ( 14.5 )	37.1 ( 12.6 )	38.7 ( 5.2 )

No statistical analyses for this end point

Primary: Pharmacokinetics of daptomycin: Area under the plasma concentration-time curve

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End point title

Pharmacokinetics of daptomycin: Area under the plasma concentration-time curve ^[2]

End point description

Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) presented in micrograms times hours per millilitre.

End point type

Primary

End point timeframe

Pre-dose, at end of infusion, and 1 hours, 2 hours, 6 hours, and 12 hours after the start of infusion.

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 a Phase 1, single dose, open-label, non-comparative study and therefore only descriptive analyses were performed. No statistical tests were performed.

End point values	Daptomycin 6 mg/kg: Ages 13 months to 24 months	Daptomycin 4 mg/kg: Ages 7 months to 12 months	Daptomycin 4 mg/kg: Ages 3 months to 6 months
Number of subjects analysed	5	7	7
Units: micrograms times hours per millilitre
arithmetic mean (standard deviation)	281.5 ( 44.5 )	219.3 ( 66.8 )	215 ( 68.3 )

No statistical analyses for this end point

Primary: Pharmacokinetics of daptomycin: Time to maximum concentration

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End point title

Pharmacokinetics of daptomycin: Time to maximum concentration ^[3]

End point description

Time to maximum concentration (Tmax) in hours defined as the sampling time at which Cmax occurred, obtained directly from the experimental plasma concentration time data, without interpolation.

End point type

Primary

End point timeframe

Pre-dose, at end of infusion, and 1 hours, 2 hours, 6 hours, and 12 hours after the start of infusion.

Notes
[3] - 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 a Phase 1, single dose, open-label, non-comparative study and therefore only descriptive analyses were performed. No statistical tests were performed.

End point values	Daptomycin 6 mg/kg: Ages 13 months to 24 months	Daptomycin 4 mg/kg: Ages 7 months to 12 months	Daptomycin 4 mg/kg: Ages 3 months to 6 months
Number of subjects analysed	5	7	7
Units: hours
arithmetic mean (standard deviation)	0.66 ( 0.26 )	0.59 ( 0.2 )	0.53 ( 0.02 )

No statistical analyses for this end point

Primary: Pharmacokinetics of daptomycin: Half-life

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End point title

Pharmacokinetics of daptomycin: Half-life ^[4]

End point description

The apparent elimination half-life (t1/2) of daptomycin presented in hours calculated as natural logarithm of 2 divided by the terminal slope of the concentration versus time curve (Kel).

End point type

Primary

End point timeframe

Pre-dose, at end of infusion, and 1 hours, 2 hours, 6 hours, and 12 hours after the start of infusion.

Notes
[4] - 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 a Phase 1, single dose, open-label, non-comparative study and therefore only descriptive analyses were performed. No statistical tests were performed.

End point values	Daptomycin 6 mg/kg: Ages 13 months to 24 months	Daptomycin 4 mg/kg: Ages 7 months to 12 months	Daptomycin 4 mg/kg: Ages 3 months to 6 months
Number of subjects analysed	5	7	7
Units: Hours
arithmetic mean (standard deviation)	4.41 ( 0.94 )	5.45 ( 1.13 )	5.1 ( 1.17 )

No statistical analyses for this end point

Primary: Pharmacokinetics of daptomycin: Clearance

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End point title

Pharmacokinetics of daptomycin: Clearance ^[5]

End point description

Plasma clearance (CL) calculated as dose divided by AUC0-∞ is presented in millilitres per hour(s) per kilogram.

End point type

Primary

End point timeframe

Pre-dose, at end of infusion, and 1 hours, 2 hours, 6 hours, and 12 hours after the start of infusion.

Notes
[5] - 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 a Phase 1, single dose, open-label, non-comparative study and therefore only descriptive analyses were performed. No statistical tests were performed.

End point values	Daptomycin 6 mg/kg: Ages 13 months to 24 months	Daptomycin 4 mg/kg: Ages 7 months to 12 months	Daptomycin 4 mg/kg: Ages 3 months to 6 months
Number of subjects analysed	5	7	7
Units: millilitre(s) per hour(s) per kilogram
arithmetic mean (standard deviation)	21.76 ( 2.99 )	19.63 ( 5.76 )	19.72 ( 5.46 )

No statistical analyses for this end point

Primary: Pharmacokinetics of daptomycin: Volume of distribution

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End point title

Pharmacokinetics of daptomycin: Volume of distribution ^[6]

End point description

Steady state weight adjusted volume of distribution (Vss) presented in millilitres per kilogram calculated as a product of CL and mean residence time.

End point type

Primary

End point timeframe

Pre-dose, at end of infusion, and 1 hours, 2 hours, 6 hours, and 12 hours after the start of infusion.

Notes
[6] - 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 a Phase 1, single dose, open-label, non-comparative study and therefore only descriptive analyses were performed. No statistical tests were performed.

End point values	Daptomycin 6 mg/kg: Ages 13 months to 24 months	Daptomycin 4 mg/kg: Ages 7 months to 12 months	Daptomycin 4 mg/kg: Ages 3 months to 6 months
Number of subjects analysed	5	7	7
Units: Millilitre(s) per kilogram
arithmetic mean (standard deviation)	121.7 ( 30.7 )	134.9 ( 28.6 )	127.7 ( 11.7 )

No statistical analyses for this end point

Secondary: Safety of daptomycin: Treatment-emergent related adverse events

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End point title

Safety of daptomycin: Treatment-emergent related adverse events

End point description

The number of subjects with at least one treatment-emergent related adverse event was reported by dosing group.

End point type

Secondary

End point timeframe

Up to 9 days after dosing.

End point values	Daptomycin 6 mg/kg: Ages 13 months to 24 months	Daptomycin 4 mg/kg: Ages 7 months to 12 months	Daptomycin 4 mg/kg: Ages 3 months to 6 months
Number of subjects analysed	7	8	9
Units: Subjects	0	3	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Up through 9 days post-dose.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

12.0

Reporting group title

Daptomycin 6 mg/kg: Ages 13 months to 24 months

Reporting group description

Subjects aged 13 months to 24 months inclusive received a single dose of i.v. daptomycin 6 mg/kg over a duration of 30 minutes.

Reporting group title

Daptomycin 4 mg/kg: Ages 3 months to 6 months

Reporting group description

Subjects aged 3 months to 6 months inclusive received a single dose of i.v. daptomycin 4 mg/kg over a duration of 30 minutes.

Reporting group title

Daptomycin 4 mg/kg: Ages 7 months to 12 months

Reporting group description

Subjects aged 7 months to 12 months inclusive received a single dose of i.v. daptomycin 4 mg/kg over a duration of 30 minutes.

Serious adverse events	Daptomycin 6 mg/kg: Ages 13 months to 24 months	Daptomycin 4 mg/kg: Ages 3 months to 6 months	Daptomycin 4 mg/kg: Ages 7 months to 12 months
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 8 (12.50%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 8 (12.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Daptomycin 6 mg/kg: Ages 13 months to 24 months	Daptomycin 4 mg/kg: Ages 3 months to 6 months	Daptomycin 4 mg/kg: Ages 7 months to 12 months
Total subjects affected by non serious adverse events
subjects affected / exposed	2 / 7 (28.57%)	3 / 9 (33.33%)	6 / 8 (75.00%)
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	1
Aspartate aminotransferase increased
subjects affected / exposed	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	1
Blood creatine phosphokinase increased
subjects affected / exposed	0 / 7 (0.00%)	0 / 9 (0.00%)	3 / 8 (37.50%)
occurrences all number	0	0	3
Eosinophil count increased
subjects affected / exposed	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 8 (0.00%)
occurrences all number	0	1	0
Urine output decreased
subjects affected / exposed	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	1
Nervous system disorders
Hyperreflexia
subjects affected / exposed	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 8 (0.00%)
occurrences all number	0	1	0
Hypertonia
subjects affected / exposed	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 8 (0.00%)
occurrences all number	0	1	0
General disorders and administration site conditions
Irritability
subjects affected / exposed	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	1
Pyrexia
subjects affected / exposed	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 8 (0.00%)
occurrences all number	1	0	0
Gastrointestinal disorders
Constipation
subjects affected / exposed	0 / 7 (0.00%)	2 / 9 (22.22%)	0 / 8 (0.00%)
occurrences all number	0	2	0
Diarrhoea
subjects affected / exposed	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 8 (0.00%)
occurrences all number	1	0	0
Teething
subjects affected / exposed	1 / 7 (14.29%)	0 / 9 (0.00%)	1 / 8 (12.50%)
occurrences all number	1	0	1
Skin and subcutaneous tissue disorders
Dermatitis diaper
subjects affected / exposed	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 8 (0.00%)
occurrences all number	1	0	0
Rash
subjects affected / exposed	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	1
Rash macular
subjects affected / exposed	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	2
Rash maculo-papular
subjects affected / exposed	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	2
Skin exfoliation
subjects affected / exposed	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	1
Infections and infestations
Otitis media
subjects affected / exposed	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	1
Metabolism and nutrition disorders
Hypophagia
subjects affected / exposed	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 8 (12.50%)
occurrences all number	0	0	1

More information

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Were there any global substantial amendments to the protocol? Yes

19 Nov 2009

• Dosing for Group 1 (ages 13 months to 24 months) was changed from 9 mg/kg over a 1 hour infusion to 6 mg/kg over a 30 minute infusion. In addition, infusion times were updated for Group 2 (ages 7 months to 12 months)and Group 3 (ages 3 months to 6 months) to include the possibility of a 30 minute infusion. • Enrollment was to begin with Group 1. • Pharmacokinetic sampling time points were adjusted accordingly to account for the revised dosing.

02 Sep 2010

• Based on the review of clinical data from 4 infants in Age Group 1, the dose of study medication was reduced to 4 mg/kg administered over 30 minutes for children younger than 13 months of age (Age Groups 2 and 3). The 6 mg/kg dose, administered over 30 minutes, was continued for Age Group 1. Age Groups 2 and 3 were to be enrolled simultaneously. • An inclusion criterion was added that requires the presence of two patent i.v. lines (or comparable means of venous access) prior to dosing on Study Day 1. • The timing of PK plasma sample collection was revised to reflect the revised infusion schedule.

20 Jul 2011

• The option for a 1 hour or 2 hour infusion was removed since both dose groups received 4 mg/kg which was infused over 30 minutes. • The Baseline evaluation screening window was changed from 48 hour prior to dosing to 2 weeks prior to dosing to allow a larger window for screening. • To account for the difficulty placing 12 leads on the subjects in the youngest age group, the requirement for a 12-lead ECG was changed to an ECG. • Revision of inclusion criterion 5 to state that subjects had to have suspected or diagnosed bacterial infection instead of a gram positive infection. The subject was also to have received standard antibiotic therapy, including prophylactic use of antibiotics peri-operatively. • Revisions of various other inclusion and exclusion criteria. • Concomitant antibiotics and medications and concurrent procedures was revised to account for the inclusion of surgical subjects. The following changes were made: the requirements that surgical procedures could not be performed within 24 hours prior to dosing and that subjects were not to plan procedures in the 24 hours following dosing were deleted. • The number of samples required for PK collection was reduced from 6 to 5, thus eliminating the pre-dose draw.

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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Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Pharmacokinetics of daptomycin: Maximum plasma concentration

Primary: Pharmacokinetics of daptomycin: Maximum plasma concentration

Primary: Pharmacokinetics of daptomycin: Area under the plasma concentration-time curve

Primary: Pharmacokinetics of daptomycin: Area under the plasma concentration-time curve

Primary: Pharmacokinetics of daptomycin: Time to maximum concentration

Primary: Pharmacokinetics of daptomycin: Time to maximum concentration

Primary: Pharmacokinetics of daptomycin: Half-life

Primary: Pharmacokinetics of daptomycin: Half-life

Primary: Pharmacokinetics of daptomycin: Clearance

Primary: Pharmacokinetics of daptomycin: Clearance

Primary: Pharmacokinetics of daptomycin: Volume of distribution

Primary: Pharmacokinetics of daptomycin: Volume of distribution

Secondary: Safety of daptomycin: Treatment-emergent related adverse events

Secondary: Safety of daptomycin: Treatment-emergent related adverse events

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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