Trial · NCT00589693
To Compare Safety and Efficacy of Doripenem Versus Imipenem-Cilastatin in Patients With Ventilator-Associated Pneumonia
NCT00589693, Phase 3, Terminated, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2012-07-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. To Compare Safety and Efficacy of Doripenem Versus Imipenem-Cilastatin in Patients With Ventilator-Associated Pneumonia. Trials, record NCT00589693. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00589693
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Compare Safety and Efficacy of Doripenem Versus Imipenem-Cilastatin in Patients With Ventilator-Associated Pneumonia
- NCT number
- NCT00589693
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 274 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Ventilator-Associated Pneumonia
- Interventions
- Doripenem, Imipenem-Cilastatin, Placebo
- First posted
- 2008-01-10
- Last updated
- 2012-12-28
- Other registries' IDs
- eudract:2007-004646-33
- Results first posted
- 2012-07-18
- Limitations and caveats
- 41 patients (21 doripenem, 20 imipenem-cilastatin) were enrolled at 5 sites that were found to be Good Clinical Practice non-compliant and were excluded from the primary efficacy and safety analyses.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Cure Rate at the End-of-treatment (EOT) Visit | End-of-treatment (Day 10 or Day 11) | The number of patients who achieved clinical cure at the EOT visit on Day 10. The patient's were classified as clinical cure if they had resolution of signs and symptoms and objective findings of pneumonia to such an extent that no further antimicrobial therapy was necessary. |
| Secondary | Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom a Qualifying P. Aeruginosa Was Isolated at Baseline | End-of-treatment (Day 10 or Day 11) | The clinical cure rate at the EOT visit in patients, whose bronchoalveolar lavage (BAL) or mini-BAL culture results yielded qualifying pneumonia pathogen P. aeruginosa at baseline. |
| Secondary | Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom at Least 1 of the Gram-negative Qualifying Pneumonia Pathogens (Enterobacteriaceae, P. Aeruginosa, and Acinetobacter Spp) Was Isolated at Baseline | End-of-treatment (Day 10 or Day 11) | The clinical cure rate at the EOT visit in patients whose BAL or mini-BAL culture results yielded at least 1 of the following Gram-negative qualifying pneumonia pathogens was isolated at baseline: any Enterobacteriaceae, P. aeruginosa, and Acinetobacter Spp. |
| Secondary | Number of Patients Who Had Emergence of P. Aeruginosa Resistance | Up to 6 weeks | Number of patients who had P. aeruginosa isolates with a 4 fold or greater increase in minimum inhibitory concentration (MIC) at anytime during the study (after the study medication is received) from baseline |
| Secondary | 28-day All-cause Mortality Rate | Up to 28 days | Number of deaths which occured up to 28 days of the study period due to all causes |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Cure Rate at the End-of-treatment (EOT) Visit | End-of-treatment (Day 10 or Day 11) | Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen. | Participants | NUMBER |
| SECONDARY | Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom a Qualifying P. Aeruginosa Was Isolated at Baseline | End-of-treatment (Day 10 or Day 11) | Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen. | Participants | NUMBER |
| SECONDARY | Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom at Least 1 of the Gram-negative Qualifying Pneumonia Pathogens (Enterobacteriaceae, P. Aeruginosa, and Acinetobacter Spp) Was Isolated at Baseline | End-of-treatment (Day 10 or Day 11) | Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen. | Participants | NUMBER |
| SECONDARY | Number of Patients Who Had Emergence of P. Aeruginosa Resistance | Up to 6 weeks | Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen. | Participants | NUMBER |
| SECONDARY | 28-day All-cause Mortality Rate | Up to 28 days | Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Cure Rate at the End-of-treatment (EOT) Visit | Doripenem | 36 | Participants | ||
| Clinical Cure Rate at the End-of-treatment (EOT) Visit | Imipenem-cilastatin | 50 | Participants | ||
| Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom a Qualifying P. Aeruginosa Was Isolated at Baseline | Doripenem | 7 | Participants | ||
| Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom a Qualifying P. Aeruginosa Was Isolated at Baseline | Imipenem-cilastatin | 6 | Participants | ||
Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom at Least 1 of the Gram-negative Qualifying Pneumonia Pathogens (Enterobacteriaceae, P. Aeruginosa, and Acinetobacter Spp) Was Isolated at Baseline | Doripenem | 32 | Participants | ||
Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom at Least 1 of the Gram-negative Qualifying Pneumonia Pathogens (Enterobacteriaceae, P. Aeruginosa, and Acinetobacter Spp) Was Isolated at Baseline | Imipenem-cilastatin | 34 | Participants | ||
| Number of Patients Who Had Emergence of P. Aeruginosa Resistance | Doripenem | 3 | Participants | ||
| Number of Patients Who Had Emergence of P. Aeruginosa Resistance | Imipenem-cilastatin | 6 | Participants | ||
| 28-day All-cause Mortality Rate | Doripenem | 17 | Participants | ||
| 28-day All-cause Mortality Rate | Imipenem-cilastatin | 13 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Doripenem | 115 | |
| Overall Study | STARTED | Imipenem-cilastatin | 112 | |
| Overall Study | COMPLETED | Doripenem | 71 | |
| Overall Study | COMPLETED | Imipenem-cilastatin | 83 | |
| Overall Study | NOT COMPLETED | Doripenem | 44 | |
| Overall Study | NOT COMPLETED | Imipenem-cilastatin | 29 |
Source ClinicalTrials.gov
Adverse events250
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 | Diarrhoea | Gastrointestinal disorders | Doripenem | 11 | 115 | |
| other | Diarrhoea | Gastrointestinal disorders | Imipenem-cilastatin | 12 | 112 | |
| other | Constipation | Gastrointestinal disorders | Doripenem | 9 | 115 | |
| other | Constipation | Gastrointestinal disorders | Imipenem-cilastatin | 11 | 112 | |
| other | Vomiting | Gastrointestinal disorders | Doripenem | 6 | 115 | |
| other | Vomiting | Gastrointestinal disorders | Imipenem-cilastatin | 6 | 112 | |
| other | Nausea | Gastrointestinal disorders | Doripenem | 5 | 115 | |
| other | Nausea | Gastrointestinal disorders | Imipenem-cilastatin | 7 | 112 | |
| other | Depression | Psychiatric disorders | Doripenem | 14 | 115 | |
| other | Depression | Psychiatric disorders | Imipenem-cilastatin | 8 | 112 |
1 to 10 of 250Source ClinicalTrials.gov
See all 250 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Doripenem | ||
| Total, all-cause mortality | Imipenem-cilastatin | ||
| Total, other adverse events | Doripenem | 82 | 115 |
| Total, other adverse events | Imipenem-cilastatin | 80 | 112 |
| Total, serious adverse events | Doripenem | 55 | 115 |
| Total, serious adverse events | Imipenem-cilastatin | 45 | 112 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23148736 | DERIVED |
Source PubMed
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Doripenem vs Imipenem-cilastatin: Clinical Cure Rate at the End-of-treatment (EOT) Visit | Trial comparisons |
| Doripenem vs Imipenem-cilastatin: 28-day All-cause Mortality Rate | Trial comparisons |
| Doripenem vs Imipenem-cilastatin: Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom a Qualifying P. Aeruginosa Was Isolated at Baseline | Trial comparisons |
| Doripenem vs Imipenem-cilastatin: Number of Patients Who Had Emergence of P. Aeruginosa Resistance | Trial comparisons |
Doripenem vs Imipenem-cilastatin: Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom at Least 1 of the Gram-negative Qualifying Pneumonia Pathogens (Enterobacteriaceae, P. Aeruginosa, and Acinetobacter Spp) Was Isolated at Baseline | Trial comparisons |
| Doripenem vs Imipenem-cilastatin: 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/NCT00589693
GET https://conductscience.org/api/trials/v1/NCT00589693/events?page=2