Trial · NCT00515034
A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia
NCT00515034, Phase 2, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2010-06-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia. Trials, record NCT00515034. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00515034
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia
- NCT number
- NCT00515034
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 146 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Pneumonia, Ventilator-Associated, Pneumonia, Bacterial, Pneumonia, Abdominal Abscess, Bacterial Infections
- Interventions
- Imipenem/cilastatin, Imipenem/cilastatin, Doripenem, Doripenem
- First posted
- 2007-08-13
- Last updated
- 2019-03-19
- Results first posted
- 2010-06-22
- Limitations and caveats
- open-label study design and limited number of subjects in the comparator group
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patients With Incidence of Treatment-emergent Adverse Events (TEAEs). | from the initiation of the first infusion of study drug therapy and up to 30 days after the completion of study drug therapy | Treatment-emergent adverse events (TEAEs) are defined as AEs with onset dates on or after the date of the start of the infusion of first dose of study therapy and within 30 days after administration of the last dose of study therapy. |
| Secondary | Patients With VAP Who Were Clinically Cured | 7 to 14 days after the end of IV therapy | clinical cure is the complete resolution of signs and symptoms of pneumonia or lack of progression of chest x-ray abnormalities to such an extent that no further antimicrobial therapy was necessary. |
| Secondary | Patients With cIAI Who Were Clinically Cured | 7 to 14 days after the end of IV therapy | clinical cure is the complete resolution or significant improvement of signs or symptoms of cIAI, such that no additional antimicrobial therapy or surgical or percutaneous intervention is required for the treatment of the current infection. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patients With Incidence of Treatment-emergent Adverse Events (TEAEs). | from the initiation of the first infusion of study drug therapy and up to 30 days after the completion of study drug therapy | population is the as-treated analysis set - that is subjects who were administered therapy | participants | NUMBER |
| SECONDARY | Patients With VAP Who Were Clinically Cured | 7 to 14 days after the end of IV therapy | the population is the number of participants who are clinically evaluable | participants | NUMBER |
| SECONDARY | Patients With cIAI Who Were Clinically Cured | 7 to 14 days after the end of IV therapy | participants who were clinically evaluable | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patients With Incidence of Treatment-emergent Adverse Events (TEAEs). | VAP Treated With Doripenem | 42 | participants | ||
| Patients With Incidence of Treatment-emergent Adverse Events (TEAEs). | VAP Treated With Imipenem/Cilastatin | 13 | participants | ||
| Patients With Incidence of Treatment-emergent Adverse Events (TEAEs). | cIAI Treated With Doripenem | 37 | participants | ||
| Patients With Incidence of Treatment-emergent Adverse Events (TEAEs). | cIAI Treated With Imipenem/Cilastatin | 15 | participants | ||
| Patients With VAP Who Were Clinically Cured | VAP Treated With Doripenem | 16 | participants | ||
| Patients With VAP Who Were Clinically Cured | VAP Treated With Imipenem/Cilastatin | 7 | participants | ||
| Patients With cIAI Who Were Clinically Cured | cIAI Treated With Doripenem | 39 | participants | ||
| Patients With cIAI Who Were Clinically Cured | cIAI Treated With Imipenem/Cilastatin | 9 | participants |
Source ClinicalTrials.gov
Participant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | VAP Treated With Doripenem | 49 | |
| Overall Study | STARTED | VAP Treated With Imipenem/Cilastatin | 15 | |
| Overall Study | STARTED | cIAI Treated With Doripenem | 62 | |
| Overall Study | STARTED | cIAI Treated With Imipenem/Cilastatin | 20 | |
| Overall Study | TREATED | VAP Treated With Doripenem | 48 | |
| Overall Study | TREATED | VAP Treated With Imipenem/Cilastatin | 15 | |
| Overall Study | TREATED | cIAI Treated With Doripenem | 61 | |
| Overall Study | TREATED | cIAI Treated With Imipenem/Cilastatin | 19 | |
| Overall Study | COMPLETED | VAP Treated With Doripenem | 41 | |
| Overall Study | COMPLETED | VAP Treated With Imipenem/Cilastatin | 13 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events268
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 | VAP Treated With Doripenem | 9 | 48 | 9 |
| other | Anaemia | Blood and lymphatic system disorders | VAP Treated With Imipenem/Cilastatin | 1 | 15 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | cIAI Treated With Doripenem | 1 | 61 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | cIAI Treated With Imipenem/Cilastatin | 1 | 19 | 1 |
| other | bronchospasm | Respiratory, thoracic and mediastinal disorders | VAP Treated With Doripenem | 6 | 48 | 6 |
| other | bronchospasm | Respiratory, thoracic and mediastinal disorders | VAP Treated With Imipenem/Cilastatin | 0 | 15 | 0 |
| other | bronchospasm | Respiratory, thoracic and mediastinal disorders | cIAI Treated With Doripenem | 0 | 61 | 0 |
| other | bronchospasm | Respiratory, thoracic and mediastinal disorders | cIAI Treated With Imipenem/Cilastatin | 0 | 19 | 0 |
| other | constipation | Gastrointestinal disorders | VAP Treated With Doripenem | 3 | 48 | 3 |
| other | constipation | Gastrointestinal disorders | VAP Treated With Imipenem/Cilastatin | 3 | 15 | 3 |
1 to 10 of 268Source ClinicalTrials.gov
See all 268 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | VAP Treated With Doripenem | ||
| Total, all-cause mortality | VAP Treated With Imipenem/Cilastatin | ||
| Total, all-cause mortality | cIAI Treated With Doripenem | ||
| Total, all-cause mortality | cIAI Treated With Imipenem/Cilastatin | ||
| Total, other adverse events | VAP Treated With Doripenem | 42 | 48 |
| Total, other adverse events | VAP Treated With Imipenem/Cilastatin | 13 | 15 |
| Total, other adverse events | cIAI Treated With Doripenem | 37 | 61 |
| Total, other adverse events | cIAI Treated With Imipenem/Cilastatin | 15 | 19 |
| Total, serious adverse events | VAP Treated With Doripenem | 16 | 48 |
| Total, serious adverse events | VAP Treated With Imipenem/Cilastatin | 4 | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00515034
GET https://conductscience.org/api/trials/v1/NCT00515034/events?page=2