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A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Daiyukai First Hospital
Ichinomiya, Aichi, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Intra-abdominal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16-79 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Known or suspected hypersensitivity, intolerance or contraindication to Metronidazole,
Ceftriaxone sodium, or other cephem antibiotics.

- Severe renal dysfunction (creatinine clearance 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.

NCT01473836
Pfizer
Completed
A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection

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A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection
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
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Intra-abdominal Infections
  • 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
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
Interventions:
  • Drug: Metronidazole
  • Drug: Ceftriaxone sodium
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
October 2012
October 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years to 79 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01473836
A6831005
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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