Clinical Trial Results:
An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics and Safety of Doripenem in Pediatric Subjects 6 to 17 Years of age, Inclusive, With Cystic Fibrosis
Due to a system error, the data reported in v1 is not correct and has been removed from public view.
Summary
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EudraCT number |
2015-001225-16 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
24 Mar 2010
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Results information
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Results version number |
v2(current) |
This version publication date |
02 Jun 2016
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First version publication date |
24 Jul 2015
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Other versions |
v1 (removed from public view) |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
DORIPED1001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Johnson & Johnson Pharmaceutical Research & Development
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Sponsor organisation address |
Clinical Registry Group-JB BV Archimedesweg 29 , Leiden, Netherlands, 2333CM
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Public contact |
Clinical Registry Group-JB BV, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group-JB BV, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
24 Mar 2010
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
24 Mar 2010
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study was to assess the pharmacokinetics of doripenem after a single administration of 30 milligram per kilogram of body weight (mg/kg) of doripenem as 4 hour intravenous (IV) infusion administered to paediatric subjects with cystic fibrosis (CF).
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Protection of trial subjects |
This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety was assessed based on treatment-emergent adverse events (TEAEs), including pre-study to post-study changes in physical examination findings, vital sign measurements, and clinical laboratory analyte values. A safety committee was established to ensure that the safety of the subjects was not compromised.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 May 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 22
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Worldwide total number of subjects |
22
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
10
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Adolescents (12-17 years) |
12
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||
Pre-assignment
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Screening details |
Twenty-two subjects were enrolled into the study. | ||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group 1 | ||||||||||||||||||
Arm description |
Subjects more than or equal to (>=) 6 to less than (<) 12 years with CF who were receiving treatment with another non-study antibiotic for an infection, colonization, or prophylaxis in a hospital or supervised outpatient clinic setting were observed. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Doripenem
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Investigational medicinal product code |
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Other name |
Doribax
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous drip use
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Dosage and administration details |
Subjects were given a single dose of doripenem 30 milligram per kilogram of body weight (mg/kg) for 4 hour as IV infusion.
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Arm title
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Group 2 | ||||||||||||||||||
Arm description |
Subjects >=12 to < 18 years with CF who were receiving treatment with another non-study antibiotic for an infection, colonization, or prophylaxis in a hospital or supervised outpatient clinic setting were observed. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Doripenem
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Investigational medicinal product code |
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Other name |
Doribax
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous drip use
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Dosage and administration details |
Subjects were given a single dose of doripenem 30 mg/kg for 4 hour as IV infusion. The maximum dose of doripenem was 1000 mg.
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Baseline characteristics reporting groups
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Reporting group title |
Group 1
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Reporting group description |
Subjects more than or equal to (>=) 6 to less than (<) 12 years with CF who were receiving treatment with another non-study antibiotic for an infection, colonization, or prophylaxis in a hospital or supervised outpatient clinic setting were observed. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2
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Reporting group description |
Subjects >=12 to < 18 years with CF who were receiving treatment with another non-study antibiotic for an infection, colonization, or prophylaxis in a hospital or supervised outpatient clinic setting were observed. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group 1
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Reporting group description |
Subjects more than or equal to (>=) 6 to less than (<) 12 years with CF who were receiving treatment with another non-study antibiotic for an infection, colonization, or prophylaxis in a hospital or supervised outpatient clinic setting were observed. | ||
Reporting group title |
Group 2
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Reporting group description |
Subjects >=12 to < 18 years with CF who were receiving treatment with another non-study antibiotic for an infection, colonization, or prophylaxis in a hospital or supervised outpatient clinic setting were observed. | ||
Subject analysis set title |
Pharmacokinetic Analysis Set
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Pharmacokinetic analysis set included all enrolled subjects who received study drug, and had Maximum Observed Plasma Concentration (Cmax) estimation.
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End point title |
Maximum Observed Plasma Concentration (Cmax) [1] | ||||||||||||
End point description |
The Cmax is the maximum observed plasma concentration.
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End point type |
Primary
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End point timeframe |
Pre-dose, 2.00, 4.00, 4.50, 5.00, 7.00, 9.00 hour after intravenous infusion
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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: Descriptive statistics were done, no inferential statistical analyses were performed |
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Notes [2] - Pharmacokinetic Analysis Set [3] - Pharmacokinetic Analysis Set |
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No statistical analyses for this end point |
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End point title |
Time to Reach Maximum Observed Plasma Concentration (Tmax) [4] | ||||||||||||
End point description |
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
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End point type |
Primary
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End point timeframe |
Pre-dose, 2, 4, 4.5, 5, 7, 9 hours after intravenous infusion
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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: Descriptive statistics were done, no inferential statistical analyses were performed |
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Notes [5] - Pharmacokinetic Analysis Set [6] - Pharmacokinetic Analysis Set |
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No statistical analyses for this end point |
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End point title |
Area Under the Plasma Concentration-Time Curve From Time Zero to last quantifiable time (AUC[0-last]) [7] | ||||||||||||
End point description |
AUC (last) is area under the plasma concentration-time curve from time zero to last quantifiable time.
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End point type |
Primary
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End point timeframe |
Pre-dose, 2, 4, 4.5, 5, 7, 9 hours after intravenous infusion
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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: Descriptive statistics were done, no inferential statistical analyses were performed |
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Notes [8] - Pharmacokinetic Analysis Set [9] - Pharmacokinetic Analysis Set |
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No statistical analyses for this end point |
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End point title |
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) [10] | ||||||||||||
End point description |
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C (last)/lambda (z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
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End point type |
Primary
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End point timeframe |
Pre-dose; 2, 4, 4.5, 5, 7, 9 hours after intravenous infusion
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Notes [10] - 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: Descriptive statistics were done, no inferential statistical analyses were performed |
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Notes [11] - Pharmacokinetic Analysis Set [12] - Pharmacokinetic Analysis Set |
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No statistical analyses for this end point |
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End point title |
Plasma Decay Half-Life (t1/2) [13] | ||||||||||||
End point description |
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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End point type |
Primary
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End point timeframe |
Pre-dose; 2, 4, 4.5, 5, 7, 9 hours after intravenous infusion
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Notes [13] - 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: Descriptive statistics were done, no inferential statistical analyses were performed |
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Notes [14] - Pharmacokinetic Analysis Set [15] - Pharmacokinetic Analysis Set |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Timeframe for AE
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
12.1
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Reporting groups
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Reporting group title |
Group 2
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Reporting group description |
Subjects who were receiving non-study antibiotic from >=12 years to <18 years of age was observed. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 1
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Reporting group description |
Subjects who were receiving non-study antibiotic from more than or equal to (>=) 6 years to less than (<) 12 years of age was observed. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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18 Feb 2009 |
Protocol amendment 1 included revision of inclusion criterion to allow the flexibility to enroll subjects receiving antibiotic therapy outside the hospital and also for the subjects receiving antibiotics without an IV catheter in place. Withdrawal criterion for interrupted doripenem infusion was modified from interruption more than 5 minutes to more than 10 minutes. |
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22 Jun 2009 |
Protocol amendment 2 included withdrawal from study was modified to allow re-enrollment of subjects withdrawn for reasons other than safety. Instructions regarding pharmacokinetic sample collection in the cases where study drug administration could have been interrupted for less than or equal to 10 minutes were clarified. |
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01 Oct 2009 |
Protocol amendment 3 deleted an inclusion criterion for weight requirement (within the 5th and the 95th percentile), to allow enrollment of subjects with lower body weight. Study withdrawal section and dosage and administration section were updated to clarify that the subject was to be withdrawn if the total interruption in study drug administration occurred for more than 10 minutes. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |