Trial · NCT01644643
Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens
NCT01644643, Phase 3, Completed, Pfizer; results first posted 2015-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens. Trials, record NCT01644643. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01644643
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens
- NCT number
- NCT01644643
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 345 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Complicated Urinary Tract Infection, Complicated Intra-abdominal Infection
- Interventions
- Ceftazidime - Avibactam ( CAZ-AVI), Best Available Therapy, Metronidazole
- First posted
- 2012-07-19
- Last updated
- 2017-09-29
- Results first posted
- 2015-12-14
Source ClinicalTrials.gov
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Proportion of patients with clinical cure at the TOC visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Secondary | Clinical Response at End of Treatment (EOT) in mMITT Analysis Set. | 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Proportion of patients with clinical cure at the EOT visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Secondary | Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set | cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization | Proportion of patients with clinical cure at the FU1 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Secondary | Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set | At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization | Proportion of patients with clinical cure at the FU2 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Secondary | Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set. | 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Proportion of patients with clinical cure at the EOT visit in the EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Secondary | Clinical Response at TOC in EME at TOC Analysis Set. | 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days. | Proportion of patients with clinical cure at the TOC visit in the EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Secondary | Clinical Response at FU1 in EME at FU1 Analysis Set. | cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization | Proportion of patients with clinical cure at the FU1 visit in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Secondary | Clinical Response at FU2 in EME at FU2 Analysis Set | At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization | Proportion of patients with clinical cure at the FU2 visit in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary. |
| Secondary | Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set | 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days. | Proportion of patients with clinical cure at TOC visit by baseline pathogen (\>=10% of frequency in the combined cIAI and cUTI patients) in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Secondary | Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set | 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days. | Proportion of patients with clinical cure at TOC visit by baseline Gram-negative pathogen (\>=10% of frequency in the combined cIAI and cUTI patients) in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 registered outcomesOutcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Microbiological modified intent to treat | Participant | NUMBER |
| SECONDARY | Clinical Response at End of Treatment (EOT) in mMITT Analysis Set. | 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Microbiological modified intent to treat | Participant | NUMBER |
| SECONDARY | Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set | cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization | Microbiological modified intent to treat | Participant | NUMBER |
| SECONDARY | Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set | At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization | Microbiological modified intent to treat | Participant | NUMBER |
| SECONDARY | Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set. | 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Extended Microbiological Evaluable at EOT analysis set. | Participant | NUMBER |
| SECONDARY | Clinical Response at TOC in EME at TOC Analysis Set. | 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days. | Extended Microbiological Evaluable at TOC analysis set. | Participant | NUMBER |
| SECONDARY | Clinical Response at FU1 in EME at FU1 Analysis Set. | cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization | Extended Microbiological Evaluable at FU1 analysis set. | Participant | NUMBER |
| SECONDARY | Clinical Response at FU2 in EME at FU2 Analysis Set | At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization | Extended Microbiological Evaluable at FU2 analysis set. | Participant | NUMBER |
| SECONDARY | Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set | 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days. | Microbiological modified intent to treat | Participant | NUMBER |
| SECONDARY | Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set | 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days. | Extended microbiologically evaluable at TOC | Participant | NUMBER |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 outcomesResults by group866
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | cIAI:Best Available Therapy | Clinical cure | 6 | 27.0 to 80.0 | Participant |
| Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | cIAI:CAZ-AVI + Metronidazole | Clinical cure | 8 | 86.3 to 95.4 | Participant |
| Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | cUTI:Best Available Therapy | Clinical cure | 129 | 89.3 to 97.2 | Participant |
| Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | cUTI:CAZ-AVI | Clinical cure | 132 | Participant | |
| Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | cIAI:Best Available Therapy | Clinical failure | 0 | Participant | |
| Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | cIAI:CAZ-AVI + Metronidazole | Clinical failure | 0 | Participant | |
| Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | cUTI:Best Available Therapy | Clinical failure | 2 | Participant | |
| Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | cUTI:CAZ-AVI | Clinical failure | 2 | Participant | |
| Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | cIAI:Best Available Therapy | Indeterminate | 5 | Participant | |
| Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | cIAI:CAZ-AVI + Metronidazole | Indeterminate | 2 | Participant |
1 to 10 of 866Source ClinicalTrials.gov
See all 866 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | cIAI:Best Available Therapy | 15 | |
| Overall Study | STARTED | cIAI:CAZ-AVI + Metronidazole | 12 | |
| Overall Study | STARTED | cUTI:Best Available Therapy | 153 | |
| Overall Study | STARTED | cUTI:CAZ-AVI | 153 | |
| Overall Study | COMPLETED | cIAI:Best Available Therapy | 13 | |
| Overall Study | COMPLETED | cIAI:CAZ-AVI + Metronidazole | 12 | |
| Overall Study | COMPLETED | cUTI:Best Available Therapy | 148 | |
| Overall Study | COMPLETED | cUTI:CAZ-AVI | 143 | |
| Overall Study | NOT COMPLETED | cIAI:Best Available Therapy | 2 | |
| Overall Study | NOT COMPLETED | cIAI:CAZ-AVI + Metronidazole | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events340
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 | Anaemia | Blood and lymphatic system disorders | cIAI:Best Available Therapy | 1 | 15 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | cIAI:CAZ-AVI + Metronidazole | 0 | 12 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | cUTI:Best Available Therapy | 0 | 153 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | cUTI:CAZ-AVI | 1 | 152 | 1 |
| other | Angina pectoris | Cardiac disorders | cIAI:Best Available Therapy | 1 | 15 | 1 |
| other | Angina pectoris | Cardiac disorders | cIAI:CAZ-AVI + Metronidazole | 0 | 12 | 0 |
| other | Angina pectoris | Cardiac disorders | cUTI:Best Available Therapy | 0 | 153 | 0 |
| other | Angina pectoris | Cardiac disorders | cUTI:CAZ-AVI | 0 | 152 | 0 |
| other | Arrhythmia supraventricular | Cardiac disorders | cIAI:Best Available Therapy | 1 | 15 | 1 |
| other | Arrhythmia supraventricular | Cardiac disorders | cIAI:CAZ-AVI + Metronidazole | 0 | 12 | 0 |
1 to 10 of 340Source ClinicalTrials.gov
See all 340 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | cIAI:Best Available Therapy | ||
| Total, all-cause mortality | cIAI:CAZ-AVI + Metronidazole | ||
| Total, all-cause mortality | cUTI:Best Available Therapy | ||
| Total, all-cause mortality | cUTI:CAZ-AVI | ||
| Total, other adverse events | cIAI:Best Available Therapy | 12 | 15 |
| Total, other adverse events | cIAI:CAZ-AVI + Metronidazole | 8 | 12 |
| Total, other adverse events | cUTI:Best Available Therapy | 36 | 153 |
| Total, other adverse events | cUTI:CAZ-AVI | 18 | 152 |
| Total, serious adverse events | cIAI:Best Available Therapy | 5 | 15 |
| Total, serious adverse events | cIAI:CAZ-AVI + Metronidazole | 2 | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers8
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01644643
GET https://conductscience.org/api/trials/v1/NCT01644643/registered?page=2