search
Back to results

A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection

Primary Purpose

Intra-abdominal Infections

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Metronidazole
Ceftriaxone sodium
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intra-abdominal Infections focused on measuring Metronidazole, intra-abdominal infection, pelvic inflammatory disease, anaerobe

Eligibility Criteria

16 Years - 79 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Daiyukai First Hospital
  • Hirosaki National Hospital
  • National Hospital Organization Chiba Medical Center
  • National Hospital Organization Kokura Medical Center
  • National Hospital Organization Fukuyama Medical Center
  • Hitachi General Hospital
  • Kawasaki Saiwai Hospital
  • Kumamoto Saishunso National Hospital
  • National Hospital Organization Sendai Medical Center
  • Nagano Prefectural Suzaka Hospital
  • Iida Municipal Hospital
  • National Hospital Organization Nagasaki Medical Center
  • National Hospital Organization Osaka Minami Medical Center
  • Koshigaya Municipal Hospital
  • National Hospital Organization Kumamoto Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metronidazole

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical Response: Response Rate (Investigator Assessment)
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)
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)
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)
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
Population pharmacokinetic analysis of Metronidazole is conducted by combining current study data with other Metronidazole studies.

Full Information

First Posted
October 11, 2011
Last Updated
December 18, 2013
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT01473836
Brief Title
A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection
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 Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra-abdominal Infections
Keywords
Metronidazole, intra-abdominal infection, pelvic inflammatory disease, anaerobe

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metronidazole
Arm Type
Experimental
Arm Description
Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) in combination with ceftriaxone sodium
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone sodium
Other Intervention Name(s)
ROCEPHIN
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Response: Response Rate (Data Review Committee Assessment)
Description
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.
Time Frame
Baseline to EOT (up to 14 days), TOC
Secondary Outcome Measure Information:
Title
Clinical Response: Response Rate (Investigator Assessment)
Description
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.
Time Frame
Baseline to EOT (up to 14 days), TOC
Title
Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment)
Description
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.
Time Frame
Baseline to Day 4
Title
Bacteriological Response: Eradication Rate (Data Review Committee Assessment)
Description
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.
Time Frame
Baseline to Day 4, EOT (up to 14 days), TOC
Title
Bacteriological Response: Eradication Rate (Investigator Assessment)
Description
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.
Time Frame
Baseline to Day 4, EOT (up to 14 days), TOC
Title
Number of Participants Analyzed for Population Pharmacokinetics (PK) of Metronidazole
Description
Population pharmacokinetic analysis of Metronidazole is conducted by combining current study data with other Metronidazole studies.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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 < 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Daiyukai First Hospital
City
Ichinomiya
State/Province
Aichi
Country
Japan
Facility Name
Hirosaki National Hospital
City
Hirosaki
State/Province
Aomori
Country
Japan
Facility Name
National Hospital Organization Chiba Medical Center
City
Chiba-shi
State/Province
Chiba-ken
Country
Japan
Facility Name
National Hospital Organization Kokura Medical Center
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
National Hospital Organization Fukuyama Medical Center
City
Fukuyama
State/Province
Hiroshima
Country
Japan
Facility Name
Hitachi General Hospital
City
Hitachi
State/Province
Ibaraki
Country
Japan
Facility Name
Kawasaki Saiwai Hospital
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Facility Name
Kumamoto Saishunso National Hospital
City
Koushi
State/Province
Kumamoto
Country
Japan
Facility Name
National Hospital Organization Sendai Medical Center
City
Sendai-shi
State/Province
Miyagi-ken
Country
Japan
Facility Name
Nagano Prefectural Suzaka Hospital
City
Suzaka-shi
State/Province
Nagano-ken
Country
Japan
Facility Name
Iida Municipal Hospital
City
Iida
State/Province
Nagano
Country
Japan
Facility Name
National Hospital Organization Nagasaki Medical Center
City
Ohmura
State/Province
Nagasaki
Country
Japan
Facility Name
National Hospital Organization Osaka Minami Medical Center
City
Kawachinagano
State/Province
Osaka
Country
Japan
Facility Name
Koshigaya Municipal Hospital
City
Koshigaya
State/Province
Saitama
Country
Japan
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Kumamoto
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25442806
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6831005&StudyName=A%20Phase%203%20Study%20Of%20Intravenous%20Metronidazole%20For%20Intrabdominal%20Infection
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection

We'll reach out to this number within 24 hrs