A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01473836
First received: October 11, 2011
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Intra-abdominal Infections
Drug: Metronidazole
Drug: Ceftriaxone sodium
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Clinical Response: Response Rate (Data Review Committee Assessment) [ Time Frame: Baseline to EOT (up to 14 days), TOC ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Clinical Response: Response Rate (Investigator Assessment) [ Time Frame: Baseline to EOT (up to 14 days), TOC ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment) [ Time Frame: Baseline to Day 4 ] [ Designated as safety issue: No ]
    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.

  • Bacteriological Response: Eradication Rate (Data Review Committee Assessment) [ Time Frame: Baseline to Day 4, EOT (up to 14 days), TOC ] [ Designated as safety issue: No ]
    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.

  • Bacteriological Response: Eradication Rate (Investigator Assessment) [ Time Frame: Baseline to Day 4, EOT (up to 14 days), TOC ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Analyzed for Population Pharmacokinetics (PK) of Metronidazole [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Population pharmacokinetic analysis of Metronidazole is conducted by combining current study data with other Metronidazole studies.


Enrollment: 38
Study Start Date: November 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metronidazole
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
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.
Drug: Ceftriaxone sodium
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.
Other Name: ROCEPHIN

  Eligibility

Ages Eligible for Study:   16 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 < 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473836

Locations
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
Nagano Prefectural Suzaka Hospital
Suzaka-shi, Nagano-ken, Japan
Iida Municipal Hospital
Iida, Nagano, 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
National Hospital Organization Kumamoto Medical Center
Kumamoto, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01473836     History of Changes
Other Study ID Numbers: A6831005
Study First Received: October 11, 2011
Results First Received: October 10, 2013
Last Updated: December 18, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
Metronidazole
intra-abdominal infection
pelvic inflammatory disease
anaerobe

Additional relevant MeSH terms:
Intraabdominal Infections
Infection
Ceftriaxone
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 19, 2014