A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection
NCT ID: NCT01473836
Last Updated: 2014-01-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
38 participants
INTERVENTIONAL
2011-11-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Metronidazole
Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) in combination with ceftriaxone sodium
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with intra-abdominal infections or pelvic inflammatory diseases.
* Can be obtained a specimen for bacteriological efficacy assessment.
Exclusion Criteria
* 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.
16 Years
79 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Daiyukai First Hospital
Ichinomiya, Aichi-ken, Japan
Hirosaki National Hospital
Hirosaki, Aomori, Japan
National Hospital Organization Chiba Medical Center
Chiba, Chiba, 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 Kumamoto Medical Center
Kumamoto, Kumamoto, Japan
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, Japan
Iida Municipal Hospital
Iida, Nagano, Japan
Nagano Prefectural Suzaka Hospital
Suzaka-shi, Nagano, Japan
National Hospital Organization Nagasaki Medical Center
Ohmura, Nagasaki, Japan
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Osaka, Japan
Koshigaya Municipal Hospital
Koshigaya, Saitama, Japan
Countries
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References
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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.
Related Links
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Other Identifiers
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A6831005
Identifier Type: -
Identifier Source: org_study_id
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