A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection

Intra-abdominal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473836
• Other study ID #: A6831005
• Status: Completed
• Phase: Phase 3
• First received: October 11, 2011
• Last updated: December 18, 2013
• Start date: November 2011
• Est. completion date: October 2012

Study information

• Verified date: December 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 79 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Intra-abdominal Infections
• Intraabdominal Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
Japan	National Hospital Organization Chiba Medical Center	Chiba-shi	Chiba-ken
Japan	National Hospital Organization Fukuyama Medical Center	Fukuyama	Hiroshima
Japan	Hirosaki National Hospital	Hirosaki	Aomori
Japan	Hitachi General Hospital	Hitachi	Ibaraki
Japan	Daiyukai First Hospital	Ichinomiya	Aichi
Japan	Iida Municipal Hospital	Iida	Nagano
Japan	National Hospital Organization Osaka Minami Medical Center	Kawachinagano	Osaka
Japan	Kawasaki Saiwai Hospital	Kawasaki	Kanagawa
Japan	National Hospital Organization Kokura Medical Center	Kitakyushu	Fukuoka
Japan	Koshigaya Municipal Hospital	Koshigaya	Saitama
Japan	Kumamoto Saishunso National Hospital	Koushi	Kumamoto
Japan	National Hospital Organization Kumamoto Medical Center	Kumamoto
Japan	National Hospital Organization Nagasaki Medical Center	Ohmura	Nagasaki
Japan	National Hospital Organization Sendai Medical Center	Sendai-shi	Miyagi-ken
Japan	Nagano Prefectural Suzaka Hospital	Suzaka-shi	Nagano-ken

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Baseline to EOT (up to 14 days), TOC	No
Secondary	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.	Baseline to Day 4	No
Secondary	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.	Baseline to Day 4, EOT (up to 14 days), TOC	No
Secondary	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.	Baseline to Day 4, EOT (up to 14 days), TOC	No
Secondary	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.	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.	No

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