Phase 3
Completed N=38
A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection
Intra-abdominal Infections
Source: ClinicalTrials.gov NCT01473836 ↗
Enrolled (actual)
38
Serious AEs
10.5%
Results posted
Dec 2013
Primary outcomePrimary: Clinical Response: Response Rate (Data Review Committee Assessment) — 96.6; 96.7 percentage of participants
Summary
The purpose of this study is to evaluate the clinical efficacy and safety in Japanese adult subjects with Intra-abdominal/Pelvic infections receiving Metronidazole IV 1,500-2,000 mg/day in combination with ceftriaxone sodium.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response: Response Rate (Data Review Committee Assessment) |
96.6; 96.7 | — |
| SECONDARY Clinical Response: Response Rate (Investigator Assessment) |
96.7; 100.0 | — |
| SECONDARY Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment) |
100.0 | — |
| SECONDARY Bacteriological Response: Eradication Rate (Data Review Committee Assessment) |
100.0; 100.0; 100.0 | — |
| SECONDARY Bacteriological Response: Eradication Rate (Investigator Assessment) |
100.0; 100.0; 100.0 | — |
| SECONDARY Number of Participants Analyzed for Population Pharmacokinetics (PK) of Metronidazole |
— | — |
Eligibility Criteria
Inclusion Criteria
- 16 years of age or older.
- Diagnosed with intra-abdominal infections or pelvic inflammatory diseases.
- Can be obtained a specimen for bacteriological efficacy assessment.
Exclusion Criteria
- Known or suspected hypersensitivity, intolerance or contraindication to Metronidazole, Ceftriaxone sodium, or other cephem antibiotics.
- Severe renal dysfunction (creatinine clearance 3 times upper limit of normal range values).
- Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
Data sourced from ClinicalTrials.gov (NCT01473836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.