A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection

NCT01473836 | Completed Phase 3 Results

• 1 other identifier: A6831005
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Intra-abdominal Infections

Keywords

Metronidazole; intra-abdominal infection; pelvic inflammatory disease; anaerobe

Outcome Measures

Primary Outcomes (1)

• Clinical Response: Response Rate (Data Review Committee Assessment)

  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.

  Baseline to EOT (up to 14 days), TOC

Secondary Outcomes (5)

• Clinical Response: Response Rate (Investigator Assessment)

  Baseline to EOT (up to 14 days), TOC

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

  Baseline to Day 4

• Bacteriological Response: Eradication Rate (Data Review Committee Assessment)

  Baseline to Day 4, EOT (up to 14 days), TOC

• Bacteriological Response: Eradication Rate (Investigator Assessment)

  Baseline to Day 4, EOT (up to 14 days), TOC

• 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.

Study Arms (1)

Metronidazole

EXPERIMENTAL

Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) in combination with ceftriaxone sodium

Drug: Metronidazole; Drug: Ceftriaxone sodium

Interventions

Metronidazole DRUG

Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) for 3 to 14 days, in principle. Treatment duration can be prolonged up to 21 days based on subject's condition.

Metronidazole

Ceftriaxone sodium DRUG

Ceftriaxone sodium will be administered at a daily dose of 2 g (strength) when metronidazole is administered TID or at a daily dose of 4 g (strength) when metronidazole is administered QID.

Also known as: ROCEPHIN

Metronidazole

Eligibility Criteria

• Age: 16 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older.
• Diagnosed with intra-abdominal infections or pelvic inflammatory diseases.
• Can be obtained a specimen for bacteriological efficacy assessment.

You may not qualify if:

• 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 values).
• Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (15)

Daiyukai First Hospital

Ichinomiya, Aichi-ken, Japan

Location

Hirosaki National Hospital

Hirosaki, Aomori, Japan

Location

National Hospital Organization Chiba Medical Center

Chiba, Chiba, Japan

Location

National Hospital Organization Kokura Medical Center

Kitakyushu, Fukuoka, Japan

Location

National Hospital Organization Fukuyama Medical Center

Fukuyama, Hiroshima, Japan

Location

Hitachi General Hospital

Hitachi, Ibaraki, Japan

Location

Kawasaki Saiwai Hospital

Kawasaki, Kanagawa, Japan

Location

Kumamoto Saishunso National Hospital

Koushi, Kumamoto, Japan

Location

National Hospital Organization Kumamoto Medical Center

Kumamoto, Kumamoto, Japan

Location

National Hospital Organization Sendai Medical Center

Sendai, Miyagi, Japan

Location

Iida Municipal Hospital

Iida, Nagano, Japan

Location

Nagano Prefectural Suzaka Hospital

Suzaka-shi, Nagano, Japan

Location

National Hospital Organization Nagasaki Medical Center

Ohmura, Nagasaki, Japan

Location

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, Osaka, Japan

Location

Koshigaya Municipal Hospital

Koshigaya, Saitama, Japan

Location

Related Publications (1)

• Mikamo H, Matsumizu M, Nakazuru Y, Nagashima M. Efficacy and safety of metronidazole injection for the treatment of infectious peritonitis, abdominal abscess and pelvic inflammatory diseases in Japan. J Infect Chemother. 2015 Feb;21(2):96-104. doi: 10.1016/j.jiac.2014.10.005. Epub 2014 Nov 28.

  PMID: 25442806 DERIVED

Related Links

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

MeSH Terms

Conditions

Intraabdominal Infections; Pelvic Inflammatory Disease

Interventions

Metronidazole; Ceftriaxone

Condition Hierarchy (Ancestors)

Infections; Pelvic Infection; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: November 17, 2011
• Study Start: November 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 24, 2014
• Results First Posted: December 10, 2013

Record last verified: 2013-12

Locations

JP (15)