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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
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 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.
Daiyukai First Hospital
Ichinomiya, Aichi-ken, Japan
Hirosaki National Hospital
Hirosaki, Aomori, Japan
National Hospital Organization Chiba Medical Center
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.
Time frame: Baseline to EOT (up to 14 days), TOC
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.
Time frame: Baseline to EOT (up to 14 days), TOC
Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment)
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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
...and 5 more locations
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
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.
Time frame: Baseline to Day 4, EOT (up to 14 days), TOC
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.
Time frame: Baseline to Day 4, EOT (up to 14 days), TOC
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.
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.