Trial · NCT01473836
A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection
NCT01473836, Phase 3, Completed, Pfizer; results first posted 2013-12-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection. Trials, record NCT01473836. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01473836
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection
- NCT number
- NCT01473836
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 38 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Intra-abdominal Infections
- Interventions
- Metronidazole, Ceftriaxone sodium
- First posted
- 2011-11-17
- Last updated
- 2014-01-24
- Results first posted
- 2013-12-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Response: Response Rate (Data Review Committee Assessment) | Baseline to EOT (up to 14 days), TOC | Clinical response was evaluated by the data review committee as effective (cured or improved), ineffective (not meeting "effective" criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; "number of participants evaluated as effective" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100. |
| Secondary | Clinical Response: Response Rate (Investigator Assessment) | Baseline to EOT (up to 14 days), TOC | Clinical response was evaluated by the investigator as effective (cured or improved), ineffective (not meeting "effective" criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; "number of participants evaluated as effective" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100. |
| Secondary | Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment) | Baseline to Day 4 | The appropriateness of treatment continuation was evaluated on Day 4 by the investigator as continuation, discontinuation or indeterminate based on the clinical response. The percentage of participants was calculated from the following formula; "number of participants assessed as continuation" over "total number of participants that excluding ones assessed as indeterminate" multiplied by 100. |
| Secondary | Bacteriological Response: Eradication Rate (Data Review Committee Assessment) | Baseline to Day 4, EOT (up to 14 days), TOC | Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the data review committee, at Day 4, at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, "number of participants with bacteria eradication, presumed eradication or colonization" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100. |
| Secondary | Bacteriological Response: Eradication Rate (Investigator Assessment) | Baseline to Day 4, EOT (up to 14 days), TOC | Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the investigator at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, "number of participants with bacteria eradication, presumed eradication or colonization" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100. |
| Secondary | Number of Participants Analyzed for Population Pharmacokinetics (PK) of Metronidazole | Four samples were taken at any infusion after the first dosing: during infusion, immediately after end of infusion, between 15 and 60 minutes after end of infusion, and between 2 hours and immediately before the start of the next infusion. | Population pharmacokinetic analysis of Metronidazole is conducted by combining current study data with other Metronidazole studies. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Response: Response Rate (Data Review Committee Assessment) | Baseline to EOT (up to 14 days), TOC | Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate. | percentage of participants | NUMBER |
| SECONDARY | Clinical Response: Response Rate (Investigator Assessment) | Baseline to EOT (up to 14 days), TOC | Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment) | Baseline to Day 4 | Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate. | percentage of participants | NUMBER |
| SECONDARY | Bacteriological Response: Eradication Rate (Data Review Committee Assessment) | Baseline to Day 4, EOT (up to 14 days), TOC | Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified on Day 1 prior to the initial dose. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate. | percentage of participants | NUMBER |
| SECONDARY | Bacteriological Response: Eradication Rate (Investigator Assessment) | Baseline to Day 4, EOT (up to 14 days), TOC | Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified on Day 1 prior to the initial dose. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Analyzed for Population Pharmacokinetics (PK) of Metronidazole | Four samples were taken at any infusion after the first dosing: during infusion, immediately after end of infusion, between 15 and 60 minutes after end of infusion, and between 2 hours and immediately before the start of the next infusion. | No population pharmacokinetic analysis results are available just for the current study. |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Response: Response Rate (Data Review Committee Assessment) | Metronidazole/Ceftriaxone | End of Treatment (n=30) | 96.6 | 95% Confidence Interval 82.2 to 99.9 | percentage of participants |
| Clinical Response: Response Rate (Data Review Committee Assessment) | Metronidazole/Ceftriaxone | Test of Cure (n=30) | 96.7 | 95% Confidence Interval 82.8 to 99.9 | percentage of participants |
| Clinical Response: Response Rate (Investigator Assessment) | Metronidazole/Ceftriaxone | End of Treatment (n=30) | 96.7 | 95% Confidence Interval 82.8 to 99.9 | percentage of participants |
| Clinical Response: Response Rate (Investigator Assessment) | Metronidazole/Ceftriaxone | Test of Cure (n=29) | 100.0 | 95% Confidence Interval 88.1 to 100.0 | percentage of participants |
| Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment) | Metronidazole/Ceftriaxone | 100.0 | percentage of participants | ||
| Bacteriological Response: Eradication Rate (Data Review Committee Assessment) | Metronidazole/Ceftriaxone | Day 4 | 100.0 | 95% Confidence Interval 75.3 to 100.0 | percentage of participants |
| Bacteriological Response: Eradication Rate (Data Review Committee Assessment) | Metronidazole/Ceftriaxone | End of Treatment | 100.0 | 95% Confidence Interval 83.2 to 100.0 | percentage of participants |
| Bacteriological Response: Eradication Rate (Data Review Committee Assessment) | Metronidazole/Ceftriaxone | Test of Cure | 100.0 | 95% Confidence Interval 83.9 to 100.0 | percentage of participants |
| Bacteriological Response: Eradication Rate (Investigator Assessment) | Metronidazole/Ceftriaxone | Day 4 | 100.0 | 95% Confidence Interval 75.3 to 100.0 | percentage of participants |
| Bacteriological Response: Eradication Rate (Investigator Assessment) | Metronidazole/Ceftriaxone | EOT | 100.0 | 95% Confidence Interval 83.2 to 100.0 | percentage of participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metronidazole/Ceftriaxone | 38 | |
| Overall Study | COMPLETED | Metronidazole/Ceftriaxone | 32 | |
| Overall Study | NOT COMPLETED | Metronidazole/Ceftriaxone | 6 |
Source ClinicalTrials.gov
Adverse events63
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 | Metronidazole/Ceftriaxone | 1 | 38 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Metronidazole/Ceftriaxone | 1 | 38 | |
| other | Atrial fibrillation | Cardiac disorders | Metronidazole/Ceftriaxone | 1 | 38 | |
| other | Cardiac failure | Cardiac disorders | Metronidazole/Ceftriaxone | 1 | 38 | |
| other | Sinus tachycardia | Cardiac disorders | Metronidazole/Ceftriaxone | 1 | 38 | |
| other | Stress cardiomyopathy | Cardiac disorders | Metronidazole/Ceftriaxone | 1 | 38 | |
| other | Tinnitus | Ear and labyrinth disorders | Metronidazole/Ceftriaxone | 2 | 38 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Metronidazole/Ceftriaxone | 1 | 38 | |
| other | Abdominal distension | Gastrointestinal disorders | Metronidazole/Ceftriaxone | 3 | 38 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Metronidazole/Ceftriaxone | 3 | 38 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metronidazole/Ceftriaxone | ||
| Total, other adverse events | Metronidazole/Ceftriaxone | 30 | 38 |
| Total, serious adverse events | Metronidazole/Ceftriaxone | 4 | 38 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25442806 | 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 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/NCT01473836
GET https://conductscience.org/api/trials/v1/NCT01473836/events?page=2