Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01499290 |
Recruitment Status :
Completed
First Posted : December 26, 2011
Results First Posted : March 1, 2016
Last Update Posted : September 6, 2017
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Sponsor:
Pfizer
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Pfizer
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Complicated Intra-Abdominal Infection |
Interventions |
Drug: CAZ-AVI Drug: Metronidazole Drug: Meropenem |
Enrollment | 493 |
Participant Flow
Recruitment Details | Results from two identical protocols D4280C00001 and D4280C00005 combined into a single database with agreement from FDA and EMA. First patient enrolled 22 March 2012 and last patient's last visit was 07 April 2014. Patients were adults hospitalised with complicated intra-abdominal infection (cIAI) that required surgery and IV antibiotics. |
Pre-assignment Details | After obtaining written informed consent patients underwent a preliminary evaluation for eligibility within the 24-hour period prior to initiation of IV study therapy. eligible patients were randomized to 1 of 2 treatment groups in a 1:1 ratio according to the central randomization schedule. |
Arm/Group Title | CAZ-AVI + Metronidazole | Meropenem |
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CAZ (2000mg)/AVI (500mg): IV treatment | 1000 mg: IV treatment |
Period Title: Overall Study | ||
Started | 529 [1] | 529 [1] |
Completed | 474 [2] | 494 [2] |
Not Completed | 55 | 35 |
Reason Not Completed | ||
Withdrawal by Subject | 22 | 15 |
Not specified in study report | 11 | 5 |
Condition improved/subject recovered | 1 | 0 |
Lack of Efficacy | 7 | 8 |
Adverse Event | 14 | 7 |
[1]
Patients dosed in pooled protocols D4280C00001/D4280C00005 (NCT01499290/NCT01500239) agreed with FDA
[2]
(Numbers indicate patients who completed treatment)
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Baseline Characteristics
Arm/Group Title | CAZ-AVI + Metronidazole | Meropenem | Total | |
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CAZ (2000mg)/AVI (500mg): IV treatment | 1000 mg: IV treatment | Total of all reporting groups | |
Overall Number of Baseline Participants | 520 | 523 | 1043 | |
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The MITT analysis set includes all patients who met the disease definition for cIAI and received at least 1 dose of study drug. 15 patients excluded received at least one dose of study drug but failed the minimum disease criteria.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 520 participants | 523 participants | 1043 participants | |
49.8 (17.48) | 50.3 (18.29) | 50.0 (17.88) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 520 participants | 523 participants | 1043 participants | |
Female |
194 37.3%
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191 36.5%
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385 36.9%
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Male |
326 62.7%
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332 63.5%
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658 63.1%
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Outcome Measures
Adverse Events
Limitations and Caveats
This summary describes data collected from two identical CSPs (D4280C00001 and D4280C00005). With agreement from the EMA and the FDA the data have been combined into a single study database.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The PI shall not publish results until the earliest of (i) date of the 1st study publication (joint between PI, sponsor and study sites) (ii) 18 months after study completion, or (iii) sponsor notification that no multi-center publication is to be made. The PI submits the publication for review 60 days before submission. Sponsor may embargo for a further 90 days to protect IP rights. Sponsor may request removal of confidential and/or proprietry information.
Results Point of Contact
Name/Title: | Paul Newell, Medical Science Director |
Organization: | AstraZeneca |
Phone: | +44 1625 515727 |
EMail: | paul.newell@astrazeneca.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01499290 |
Obsolete Identifiers: | NCT01500239 |
Other Study ID Numbers: |
D4280C00001 2011-003893-97 |
First Submitted: | December 19, 2011 |
First Posted: | December 26, 2011 |
Results First Submitted: | November 6, 2015 |
Results First Posted: | March 1, 2016 |
Last Update Posted: | September 6, 2017 |