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A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Intra-abdominal Infections

Intervention: Metronidazole (Drug); Ceftriaxone sodium (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical Details

Official title: A Phase 3, Multicenter, Unblind, Non-Comparative Study To Confirm Efficacy And Safety Of Intravenous Metronidazole In Patients With Intrabdominal Infection In Combination With Intravenous Ceftriaxone

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Clinical Response: Response Rate (Data Review Committee Assessment)

Secondary outcome:

Clinical Response: Response Rate (Investigator Assessment)

Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment)

Bacteriological Response: Eradication Rate (Data Review Committee Assessment)

Bacteriological Response: Eradication Rate (Investigator Assessment)

Number of Participants Analyzed for Population Pharmacokinetics (PK) of Metronidazole


Minimum age: 16 Years. Maximum age: 79 Years. Gender(s): Both.


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 < 30 mL/min.) Reference:

Cockcroft-Gault calculation formula.

- Hepatic dysfunction (AST, ALT, total bilirubin > 3 times upper limit of normal range


- Severe underlying disease; patients in which drug clinical evaluation is difficult

because of confounding diseases.

Locations and Contacts

National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan

Daiyukai First Hospital, Ichinomiya, Aichi, Japan

Hirosaki National Hospital, Hirosaki, Aomori, Japan

National Hospital Organization Chiba Medical Center, Chiba-shi, Chiba-ken, Japan

National Hospital Organization Kokura Medical Center, Kitakyushu, Fukuoka, Japan

National Hospital Organization Fukuyama Medical Center, Fukuyama, Hiroshima, Japan

Hitachi General Hospital, Hitachi, Ibaraki, Japan

Kawasaki Saiwai Hospital, Kawasaki, Kanagawa, Japan

Kumamoto Saishunso National Hospital, Koushi, Kumamoto, Japan

National Hospital Organization Sendai Medical Center, Sendai-shi, Miyagi-ken, Japan

Iida Municipal Hospital, Iida, Nagano, Japan

Nagano Prefectural Suzaka Hospital, Suzaka-shi, Nagano-ken, Japan

National Hospital Organization Nagasaki Medical Center, Ohmura, Nagasaki, Japan

National Hospital Organization Osaka Minami Medical Center, Kawachinagano, Osaka, Japan

Koshigaya Municipal Hospital, Koshigaya, Saitama, Japan

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: November 2011
Last updated: December 18, 2013

Page last updated: August 23, 2015

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