Trial · NCT01595438
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
NCT01595438, Phase 3, Completed, Pfizer; results first posted 2016-03-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections). Trials, record NCT01595438. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01595438
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
- NCT number
- NCT01595438
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 598 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
- Interventions
- Ceftazidime - Avibactam ( CAZ-AVI), Doripenem, Either switch to oral therapy: 500 mg of Ciprofloxacin (oral), or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
- First posted
- 2012-05-10
- Last updated
- 2017-09-06
- Results first posted
- 2016-03-09
Source ClinicalTrials.gov
Registered outcomes63
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test | At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time. | Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). |
| Primary | Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). |
| Primary | Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set. |
| Secondary | Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of patients with a favorable per-patient microbiological response at EOT (IV) |
| Secondary | Per-patient Microbiological Response at LFU (mMITT Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of patients with a favorable per patient microbiological response at LFU |
| Secondary | Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of patients with a favorable per-patient microbiological response at EOT (IV) |
| Secondary | Per-patient Microbiological Response at TOC (ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with a favorable per patient microbiological response at TOC |
| Secondary | Per-patient Microbiological Response at LFU (ME at LFU Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of patients with a favorable per patient microbiological response at LFU |
| Secondary | Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of patients with a favorable per-patient microbiological response at EOT (IV) |
| Secondary | Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with a favorable per patient microbiological response at TOC |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 registered outcomesOutcomes63
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test | At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time. | Microbiological modified intent to treat analysis set (mMITT) | Participants | NUMBER |
| PRIMARY | Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Microbiological modified intent to treat analysis set (mMITT) | Participants | NUMBER |
| PRIMARY | Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Microbiological modified intent to treat analysis set (mMITT) | Participants | NUMBER |
| SECONDARY | Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Microbiological modified intent to treat analysis set (mMITT) | Participants | NUMBER |
| SECONDARY | Per-patient Microbiological Response at LFU (mMITT Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Microbiological modified intent to treat analysis set (mMITT) | Participants | NUMBER |
| SECONDARY | Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV)) | Participants | NUMBER |
| SECONDARY | Per-patient Microbiological Response at TOC (ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Microbiological evaluable analysis set at TOC (ME at TOC) | Participants | NUMBER |
| SECONDARY | Per-patient Microbiological Response at LFU (ME at LFU Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Microbiological evaluable analysis set at LFU (ME at LFU) | Participants | NUMBER |
| SECONDARY | Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV)) | Participants | NUMBER |
| SECONDARY | Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Extended microbiological evaluable analysis set at TOC (Extended ME at TOC) | Participants | NUMBER |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 outcomesResults by group1,172
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test | CAZ-AVI | Symptomatic resolution | 276 | Participants | |
| Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test | Doripenem | Symptomatic resolution | 276 | Participants | |
| Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test | CAZ-AVI | Symptom persistence | 103 | Participants | |
| Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test | Doripenem | Symptom persistence | 124 | Participants | |
| Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test | CAZ-AVI | Indeterminate | 14 | Participants | |
| Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test | Doripenem | Indeterminate | 17 | Participants | |
| Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | CAZ-AVI | Favorable | 280 | Participants | |
| Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | Doripenem | Favorable | 269 | Participants | |
| Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | CAZ-AVI | Unfavorable | 81 | Participants | |
| Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | Doripenem | Unfavorable | 109 | Participants |
1 to 10 of 1,172Source ClinicalTrials.gov
See all 1,172 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 | 516 | |
| Overall Study | STARTED | Doripenem | 517 | |
| Overall Study | COMPLETED | CAZ-AVI | 473 | |
| Overall Study | COMPLETED | Doripenem | 476 | |
| Overall Study | NOT COMPLETED | CAZ-AVI | 43 | |
| Overall Study | NOT COMPLETED | Doripenem | 41 |
Source ClinicalTrials.gov
Adverse events76
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 | Constipation | Gastrointestinal disorders | CAZ-AVI | 11 | 511 | 11 |
| other | Constipation | Gastrointestinal disorders | Doripenem | 7 | 509 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | CAZ-AVI | 13 | 511 | 14 |
| other | Diarrhoea | Gastrointestinal disorders | Doripenem | 6 | 509 | 6 |
| other | Nausea | Gastrointestinal disorders | CAZ-AVI | 15 | 511 | 16 |
| other | Nausea | Gastrointestinal disorders | Doripenem | 10 | 509 | 10 |
| other | Headache | Nervous system disorders | CAZ-AVI | 38 | 511 | 41 |
| other | Headache | Nervous system disorders | Doripenem | 40 | 509 | 41 |
| serious | Angina pectoris | Cardiac disorders | CAZ-AVI | 2 | 511 | 2 |
| serious | Angina pectoris | Cardiac disorders | Doripenem | 0 | 509 | 0 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CAZ-AVI | ||
| Total, all-cause mortality | Doripenem | ||
| Total, other adverse events | CAZ-AVI | 67 | 511 |
| Total, other adverse events | Doripenem | 57 | 509 |
| Total, serious adverse events | CAZ-AVI | 21 | 511 |
| Total, serious adverse events | Doripenem | 12 | 509 |
Source ClinicalTrials.gov
Papers5
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| CAZ-AVI vs Doripenem: serious adverse events |
Source 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/NCT01595438
GET https://conductscience.org/api/trials/v1/NCT01595438/registered?page=2