Trial · NCT01499290
Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections
NCT01499290, Phase 3, Completed, Pfizer; results first posted 2016-03-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections. Trials, record NCT01499290. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01499290
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections
- NCT number
- NCT01499290
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 493 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Complicated Intra-Abdominal Infection
- Interventions
- CAZ-AVI, Metronidazole, Meropenem
- First posted
- 2011-12-26
- Last updated
- 2017-09-06
- Results first posted
- 2016-03-01
- 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.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA). | TOC: 28 to 35 days after start of study drug | The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention is necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, death where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure. Results from two identical protocols D4280C00001 and D4280C00005 combined into a single database with agreement from FDA and EMA. |
| Primary | Clinical Response at the TOC Visit in the Modified Intent-To-Treat Analysis Set (Co-primary Outcome for Rest of World [ROW]). | TOC: 28 to 35 days after start of study drug | The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, dDeath where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure. |
| Primary | Clinical Response at the TOC Visit in the Clinically Evaulable (CE) Analysis Set (Co-primary Outcome for Rest of World [ROW]). | TOC: 28 to 35 days after start of study drug | The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. |
| Secondary | Clinical Cure at TOC in the Microbiologically Evaluable Analysis Set | TOC: 28 to 35 days after start of study drug | The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. |
| Secondary | Clinical Cure at TOC in the Extended Microbiologically Evaluable Analysis Set | TOC: 28 to 35 days after start of study drug | The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. |
| Secondary | Clinical Response by Visit in the Primary Population: Microbiologically Modified Intent-to-Treat (mMITT) | EOT: within 24 hours after last dose of study drug. TOC: 28 to 35 days after start of study drug. LFU: 42 to 49 days after start of study drug | Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, dDeath where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure. |
| Secondary | Per-patient Microbiological Response in the Microbiologically Modified Intent- To-Treat Analysis Set | EOT: within 24 hours after last dose of study drug. TOC: 28 to 35 days after start of study drug. LFU 42 to 49 days after start of study drug | Microbiological responses as per the protocoled criteria: responses other than "indeterminate" were classified as "favorable" or "unfavorable." Favorable microbiological response assessments included "eradication" and "presumed eradication." Unfavorable microbiological response assessments included "persistence," "persistence with increasing minimum inhibitory concentration (MIC)," and "presumed persistence." Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to a surgical review panel (SRP) assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence). |
| Secondary | Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set. | TOC: 28 to 35 days after start of study drug. | The number of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. |
| Secondary | Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set | Test of Cure: 28 to 35 days after start of study drug | Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. |
| Secondary | Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set | TOC: 28 to 35 days after start of study drug | The number of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA). | TOC: 28 to 35 days after start of study drug | The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded. | Participants | NUMBER |
| PRIMARY | Clinical Response at the TOC Visit in the Modified Intent-To-Treat Analysis Set (Co-primary Outcome for Rest of World [ROW]). | TOC: 28 to 35 days after start of study drug | The MITT analysis set included all randomized patients who met the disease definition of cIAI and who received any amount of study drug. | Participants | NUMBER |
| PRIMARY | Clinical Response at the TOC Visit in the Clinically Evaulable (CE) Analysis Set (Co-primary Outcome for Rest of World [ROW]). | TOC: 28 to 35 days after start of study drug | The CE analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc. | Participants | NUMBER |
| SECONDARY | Clinical Cure at TOC in the Microbiologically Evaluable Analysis Set | TOC: 28 to 35 days after start of study drug | ME analysis set defined as all patients included in the CE set with at least 1 Gram negative, aerobic, susceptible pathogen in the initial/prestudy culture. | Participants | NUMBER |
| SECONDARY | Clinical Cure at TOC in the Extended Microbiologically Evaluable Analysis Set | TOC: 28 to 35 days after start of study drug | Extended ME analysis set defined as all patients included in the CE set with at least 1 Gram negative, aerobic, pathogen in the initial/prestudy culture, regardless of susceptibility. | Participants | NUMBER |
| SECONDARY | Clinical Response by Visit in the Primary Population: Microbiologically Modified Intent-to-Treat (mMITT) | EOT: within 24 hours after last dose of study drug. TOC: 28 to 35 days after start of study drug. LFU: 42 to 49 days after start of study drug | The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded. | Participants | NUMBER |
| SECONDARY | Per-patient Microbiological Response in the Microbiologically Modified Intent- To-Treat Analysis Set | EOT: within 24 hours after last dose of study drug. TOC: 28 to 35 days after start of study drug. LFU 42 to 49 days after start of study drug | The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded. | Participants | NUMBER |
| SECONDARY | Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set. | TOC: 28 to 35 days after start of study drug. | The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded. | Participants | NUMBER |
| SECONDARY | Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set | Test of Cure: 28 to 35 days after start of study drug | The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded. | Participants | NUMBER |
| SECONDARY | Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set | TOC: 28 to 35 days after start of study drug | The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded. | Participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group266
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA). | CAZ-AVI + Metronidazole | Clinical cure | 337 | Participants | |
| Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA). | Meropenem | Clinical cure | 349 | Participants | |
| Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA). | CAZ-AVI + Metronidazole | Clinical failure | 37 | Participants | |
| Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA). | Meropenem | Clinical failure | 30 | Participants | |
| Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA). | CAZ-AVI + Metronidazole | Indeterminate | 39 | Participants | |
| Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA). | Meropenem | Indeterminate | 31 | Participants | |
| Clinical Response at the TOC Visit in the Modified Intent-To-Treat Analysis Set (Co-primary Outcome for Rest of World [ROW]). | CAZ-AVI + Metronidazole | Clinical cure | 429 | Participants | |
| Clinical Response at the TOC Visit in the Modified Intent-To-Treat Analysis Set (Co-primary Outcome for Rest of World [ROW]). | Meropenem | Clinical cure | 444 | Participants | |
| Clinical Response at the TOC Visit in the Modified Intent-To-Treat Analysis Set (Co-primary Outcome for Rest of World [ROW]). | CAZ-AVI + Metronidazole | Clinical failure | 47 | Participants | |
| Clinical Response at the TOC Visit in the Modified Intent-To-Treat Analysis Set (Co-primary Outcome for Rest of World [ROW]). | Meropenem | Clinical failure | 39 | Participants |
1 to 10 of 266Source ClinicalTrials.gov
See all 266 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CAZ-AVI + Metronidazole | 529 | |
| Overall Study | STARTED | Meropenem | 529 | |
| Overall Study | COMPLETED | CAZ-AVI + Metronidazole | 474 | |
| Overall Study | COMPLETED | Meropenem | 494 | |
| Overall Study | NOT COMPLETED | CAZ-AVI + Metronidazole | 55 | |
| Overall Study | NOT COMPLETED | Meropenem | 35 |
Source ClinicalTrials.gov
Adverse events178
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Wound infection | Infections and infestations | CAZ-AVI + Metronidazole | 13 | 529 | |
| other | Wound infection | Infections and infestations | Meropenem | 11 | 529 | |
| other | Headache | Nervous system disorders | CAZ-AVI + Metronidazole | 15 | 529 | |
| other | Headache | Nervous system disorders | Meropenem | 9 | 529 | |
| other | Hypertension | Vascular disorders | CAZ-AVI + Metronidazole | 15 | 529 | |
| other | Hypertension | Vascular disorders | Meropenem | 24 | 529 | |
| other | Hypotension | Vascular disorders | CAZ-AVI + Metronidazole | 12 | 529 | |
| other | Hypotension | Vascular disorders | Meropenem | 12 | 529 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | CAZ-AVI + Metronidazole | 11 | 529 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Meropenem | 13 | 529 |
1 to 10 of 178Source ClinicalTrials.gov
See all 178 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CAZ-AVI + Metronidazole | ||
| Total, all-cause mortality | Meropenem | ||
| Total, other adverse events | CAZ-AVI + Metronidazole | 184 | 529 |
| Total, other adverse events | Meropenem | 152 | 529 |
| Total, serious adverse events | CAZ-AVI + Metronidazole | 17 | 529 |
| Total, serious adverse events | Meropenem | 15 | 529 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CAZ-AVI + Metronidazole vs Meropenem: Number of Patients Afebrile at Last Observation in the Clinically Evaluable Analysis Set for Patients Who Have Fever at Study Entry | Trial comparisons |
| CAZ-AVI + Metronidazole vs Meropenem: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01499290
GET https://conductscience.org/api/trials/v1/NCT01499290/results?page=2