Clinical Trial Results:
A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Meropenem in Hospitalized Children With Complicated Intra-Abdominal Infections.
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 |
2009-015864-32 |
Trial protocol |
LT LV Outside EU/EEA |
Global end of trial date |
09 Sep 2013
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Results information
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Results version number |
v2(current) |
This version publication date |
09 Jun 2016
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First version publication date |
23 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 |
DORIPED3001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01110382 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Janssen-Cilag International NV
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Sponsor organisation address |
Turnhoutseweg 30, 2340 Beerse , Belgium, Belgium,
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Public contact |
Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group , Janssen-Cilag International NV, 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) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000015-PIP01-07 | ||
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 |
09 Sep 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 Sep 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Sep 2013
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The primary objective of this study is to establish the safety and tolerability profile of doripenem compared with that of meropenem in hospitalized children 3 months to less than 18 years of age with cIAI
(complicated intra-abdominal infection).
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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. An Independent Data Monitoring Committee [IDMC] monitored the safety of participants in this study as well as 2 additional Phase 3 paediatric trials being conducted by the Sponsor simultaneously. Safety evaluations included the measurement of vital signs, monitoring of reported adverse effects (AEs), including serious adverse effects (SAEs), concomitant therapy, serum
chemistry, hematology assessments, and urinalysis with microscopy.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
17 Nov 2010
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Argentina: 4
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Country: Number of subjects enrolled |
Brazil: 2
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Country: Number of subjects enrolled |
Colombia: 2
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Country: Number of subjects enrolled |
Lithuania: 10
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Country: Number of subjects enrolled |
Latvia: 6
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Country: Number of subjects enrolled |
Panama: 5
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Country: Number of subjects enrolled |
United States: 12
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Worldwide total number of subjects |
41
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EEA total number of subjects |
16
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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) |
30
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Adolescents (12-17 years) |
11
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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 |
Of the 41 participants, 31 participants were assigned to treatment with doripenem and 10 participants were assigned to treatment with meropenem. | ||||||||||||||||||
Period 1
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Period 1 title |
Overall (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Doripenem | ||||||||||||||||||
Arm description |
Doripenem 20 milligram per kilogram [mg/kg] per dose (up to 500 milligram per dose [mg/dose]) was administered every 8 hours as 60-minutes intravenous [IV] (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 10 to 14 days. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Doripenem
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Doripenem 20 milligram per kilogram [mg/kg] per dose (up to 500 milligram per dose [mg/dose]) was administered every 8 hours as 60-minutes intravenous [IV] (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium).
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Arm title
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Meropenem | ||||||||||||||||||
Arm description |
Meropenem 20 milligram per kilogram [mg/kg] per dose (up to 1 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium).Total duration of treatment 10 to 14 days. | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
Meropenem
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Meropenem 20 milligram per kilogram [mg/kg] per dose (up to 1 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium).
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Baseline characteristics reporting groups
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Reporting group title |
Doripenem
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Reporting group description |
Doripenem 20 milligram per kilogram [mg/kg] per dose (up to 500 milligram per dose [mg/dose]) was administered every 8 hours as 60-minutes intravenous [IV] (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 10 to 14 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Meropenem
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Reporting group description |
Meropenem 20 milligram per kilogram [mg/kg] per dose (up to 1 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium).Total duration of treatment 10 to 14 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Doripenem
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Reporting group description |
Doripenem 20 milligram per kilogram [mg/kg] per dose (up to 500 milligram per dose [mg/dose]) was administered every 8 hours as 60-minutes intravenous [IV] (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 10 to 14 days. | ||
Reporting group title |
Meropenem
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Reporting group description |
Meropenem 20 milligram per kilogram [mg/kg] per dose (up to 1 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium).Total duration of treatment 10 to 14 days. | ||
Subject analysis set title |
Clinical Intent-to-Treat (CITT)
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All randomized participants who met the minimal disease definition of complicated intra-abdominal infection regardless if a baseline pathogen was isolated from the intra-abdominal cavity.
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Subject analysis set title |
Microbiological intent-to-treat
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Participants of CITT with at least 1 baseline bacterial pathogen isolated from the intra-abdominal cavity that was susceptible to both doripenem and meropenem. 8 and 2 participants from doripenem and meropenem, respectively had no susceptible intra-abdominal pathogen at baseline and were excluded from this set.
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End point title |
The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit | ||||||||||||
End point description |
The participants were considered as clinical cure if they had clinical improvement in signs and symptoms of the intra-abdominal infection such that no additional antibacterial therapy or surgical or percutaneous intervention is/was required for the treatment of the index infection, no fever, and a favourable response at End of IV visit.
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End point type |
Primary
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End point timeframe |
TOC (7 to 14 days after the last dose of study medication therapy)
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Notes [1] - Clinical Intent-to-Treat (CITT) [2] - Clinical Intent-to-Treat (CITT) |
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Statistical analysis title |
Statistical analysis 1 | ||||||||||||
Comparison groups |
Doripenem v Meropenem
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Number of subjects included in analysis |
41
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Analysis specification |
Pre-specified
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Analysis type |
other [3] | ||||||||||||
Method |
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Parameter type |
Difference clinical cure rates (%) | ||||||||||||
Point estimate |
4.2
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-34.7 | ||||||||||||
upper limit |
43.1 | ||||||||||||
Notes [3] - Descriptive study. |
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End point title |
The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit | ||||||||||||
End point description |
The participants were considered as clinical improved if they had clinical improvement in signs and symptoms of the intra-abdominal infection, no fever, decrease in white blood cell (WBC) , and not received any non study antibiotics for the treatment of intra-abdominal infection after IV study drug therapy had begun period at the end.
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End point type |
Secondary
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End point timeframe |
EIV (within 24 hours after completion of the last dose of IV study medication therapy)
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Notes [4] - Clinical Intent-to-Treat (CITT) [5] - Clinical Intent-to-Treat (CITT) |
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Statistical analysis title |
Statistical analysis 2 | ||||||||||||
Comparison groups |
Doripenem v Meropenem
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Number of subjects included in analysis |
41
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Analysis specification |
Pre-specified
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Analysis type |
other [6] | ||||||||||||
Method |
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Parameter type |
Difference clinical improvement rates(%) | ||||||||||||
Point estimate |
13.5
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-19.3 | ||||||||||||
upper limit |
46.4 | ||||||||||||
Notes [6] - Descriptive study. |
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End point title |
The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit | ||||||||||||
End point description |
The participants were considered as clinical cure if they had clinical improvement in signs and symptoms of the intra-abdominal infection such that no additional antibacterial therapy or surgical or percutaneous intervention is/was required for the treatment of the index infection, no fever, and a favourable response at End of IV visit.
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End point type |
Secondary
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End point timeframe |
LFU (28 to 42 days after the last dose of study medication therapy)
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Notes [7] - Clinical Intent-to-Treat (CITT) [8] - Clinical Intent-to-Treat (CITT) |
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Statistical analysis title |
Statistical analysis 3 | ||||||||||||
Comparison groups |
Doripenem v Meropenem
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Number of subjects included in analysis |
41
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Analysis specification |
Pre-specified
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Analysis type |
other [9] | ||||||||||||
Method |
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Parameter type |
Difference Clinical Cure Rate (%) | ||||||||||||
Point estimate |
11
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-30 | ||||||||||||
upper limit |
51.9 | ||||||||||||
Notes [9] - Descriptive study. |
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End point title |
The Number of Participants With Favorable Per-participant Microbiological Response | |||||||||||||||||||||
End point description |
Favourable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favourable per-participant microbiological
response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).
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End point type |
Secondary
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End point timeframe |
EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of
study medication therapy)
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Notes [10] - Microbiological intent-to-treat [11] - Microbiological intent-to-treat |
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Statistical analysis title |
Favorable Microbiological Response (MR) at EIV. | |||||||||||||||||||||
Comparison groups |
Doripenem v Meropenem
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Number of subjects included in analysis |
31
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Analysis specification |
Pre-specified
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Analysis type |
other [12] | |||||||||||||||||||||
Method |
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Parameter type |
Difference between MR rate (%) | |||||||||||||||||||||
Point estimate |
16.3
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Confidence interval |
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level |
95% | |||||||||||||||||||||
sides |
2-sided
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lower limit |
-24.3 | |||||||||||||||||||||
upper limit |
56.9 | |||||||||||||||||||||
Notes [12] - Descriptive study. |
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Statistical analysis title |
Favorable Microbiological Response (MR) at TOC. | |||||||||||||||||||||
Comparison groups |
Doripenem v Meropenem
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Number of subjects included in analysis |
31
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Analysis specification |
Pre-specified
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Analysis type |
other [13] | |||||||||||||||||||||
Method |
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Parameter type |
Difference between MR rate (%) | |||||||||||||||||||||
Point estimate |
11.4
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Confidence interval |
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level |
95% | |||||||||||||||||||||
sides |
2-sided
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lower limit |
-35.1 | |||||||||||||||||||||
upper limit |
57.9 | |||||||||||||||||||||
Notes [13] - Descriptive study. |
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Statistical analysis title |
Favorable Microbiological Response (MR) at LFU | |||||||||||||||||||||
Comparison groups |
Doripenem v Meropenem
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Number of subjects included in analysis |
31
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Analysis specification |
Pre-specified
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Analysis type |
other [14] | |||||||||||||||||||||
Method |
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Parameter type |
Difference between MR rate (%) | |||||||||||||||||||||
Point estimate |
11.4
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Confidence interval |
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level |
95% | |||||||||||||||||||||
sides |
2-sided
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lower limit |
-35.1 | |||||||||||||||||||||
upper limit |
57.9 | |||||||||||||||||||||
Notes [14] - Descriptive study. |
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End point title |
Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit | |||||||||||||||||||||
End point description |
A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and meropenem treatment groups, respectively. The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).
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End point type |
Secondary
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End point timeframe |
EIV (within 24 hours after completion of the last dose of IV study medication therapy)
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Notes [15] - Microbiological intent-to-treat [16] - Microbiological intent-to-treat |
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No statistical analyses for this end point |
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End point title |
Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit | |||||||||||||||||||||
End point description |
A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and meropenem treatment groups, respectively. The favourable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).
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End point type |
Secondary
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End point timeframe |
TOC (7 to 14 days after the last dose of study medication therapy)
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Notes [17] - Microbiological intent-to-treat [18] - Microbiological intent-to-treat |
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No statistical analyses for this end point |
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End point title |
Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit | |||||||||||||||||||||
End point description |
A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated at baseline from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated in the doripenem and meropenem treatment groups, respectively. The favourable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).
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End point type |
Secondary
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End point timeframe |
LFU (28 to 42 days after the last dose of study medication therapy)
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Notes [19] - Microbiological intent-to-treat [20] - Microbiological intent-to-treat |
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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 |
16.0
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Reporting groups
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Reporting group title |
Doripenem
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Reporting group description |
Doripenem 20 milligram per kilogram [mg/kg] per dose (up to 500 milligram per dose [mg/dose]) was administered every 8 hours as 60-minutes intravenous [IV] (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 10 to 14 days. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Meropenem
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Reporting group description |
Meropenem 20 milligram per kilogram [mg/kg] per dose (up to 1 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium).Total duration of treatment 10 to 14 days. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 3% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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31 Mar 2011 |
The overall reason for the amendment were: incorporate comments from regulatory authorities and investigators from around the world. There was change in meropenem time of intravenous bolus infusion from a 3 to 5 minute, to clarify directions and update the dosing of amoxicillin/clavulanate potassium to every 12 hours [q12h] (7:1 amoxicillin/clavulanate ratio), to allow subjects with negative intra-abdominal culture results to continue on study drug. Also to specify that subjects with recurrence of an intra-abdominal infection or who have failed prior surgical and/or medical therapy for a recent or ongoing infection may not enrol in the study. The amendment also includes the requirement that urinalysis with microscopy and creatinine clearance be calculated at baseline as well as to specify time points for the collection of safety laboratory tests. It also includes to align the protocol with the EU pediatric investigational plan (PIP) and to remove details of the IDMC that will be specified in the IDMC charter. The amended protocol includes to revise the pharmacokinetic sample collection and handling methods. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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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. | |||||||
The major limitation of the study was limited enrollment which precludes a meaningful conclusion about the efficacy and safety of doripenem compared with meropenem. |