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A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection

Last updated on November 12, 2019

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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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cIAIs Complicated Intra-Abdominal Infections
NCT02655419
All Genders
18+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Intra-abdominal Infections
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Publications *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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2012)
38
Original Estimated Enrollment  ICMJE
 (submitted: November 14, 2011)
30
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion DateOctober 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 Years to 79 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01473836
Other Study ID Numbers  ICMJE A6831005
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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