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A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01473836
First received: October 11, 2011
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Intra-abdominal Infections
 Drug: Metronidazole
Drug: Ceftriaxone sodium
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The clinical response assessed by Data Review Committee [ Time Frame: At End of Treatment (EOT); treatment duration is 3 to 14 days based on subject's condition. ] [ Designated as safety issue: No ]
  • The clinical response assessed by Data Review Committee [ Time Frame: At Test of Cure (TOC); 7 days after EOT ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The bacteriological response assessed by Data Review Committee [ Time Frame: at Day 4 ] [ Designated as safety issue: No ]
  • The bacteriological response assessed by Data Review Committee [ Time Frame: At End of Treatment (EOT); treatment duration is 3 to 14 days based on subject's condition. ] [ Designated as safety issue: No ]
  • The bacteriological response assessed by Data Review Committee [ Time Frame: At Test of Cure (TOC); 7 days after EOT ] [ Designated as safety issue: No ]
  • The clinical response assessed by Investigator [ Time Frame: At End of Treatment (EOT); treatment duration is 3 to 14 days based on subject's condition. ] [ Designated as safety issue: No ]
  • The clinical response assessed by Investigator [ Time Frame: At Test of Cure (TOC); 7 days after EOT ] [ Designated as safety issue: No ]
  • The tendency toward clinical improvement assessed by Investigator at Day 4. [ Time Frame: at Day 4 ] [ Designated as safety issue: No ]
  • The bacteriological response assessed by Investigator [ Time Frame: at Day 4 ] [ Designated as safety issue: No ]
  • The bacteriological response assessed by Investigator [ Time Frame: At End of Treatment (EOT); treatment duration is 3 to 14 days based on subject's condition. ] [ Designated as safety issue: No ]
  • The bacteriological response assessed by Investigator [ Time Frame: At Test of Cure (TOC); 7 days after EOT ] [ Designated as safety issue: No ]
  • Population Pharmacokinetics (PK) analysis [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Population Pharmacokinetics (PK) analysis [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
  • Population Pharmacokinetics (PK) analysis [ Time Frame: At End of Treatment (EOT); treatment duration is 3 to 14 days based on subject's condition. ] [ Designated as safety issue: No ]
  • Population Pharmacokinetics (PK) analysis [ Time Frame: At Test of Cure (TOC); 7 days after EOT ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: November 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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

  Eligibility

Ages Eligible for Study:   16 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473836

Locations
Japan
Daiyukai First Hospital
Ichinomiya, Aichi, Japan
Hirosaki National Hospital
Hirosaki, Aomori, Japan
National Hospital Organization Chiba Medical Center
Chiba-shi, Chiba-ken, 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 Sendai Medical Center
Sendai-shi, Miyagi-ken, Japan
Nagano Prefectural Suzaka Hospital
Suzaka-shi, Nagano-ken, Japan
Iida Municipal Hospital
Iida, Nagano, Japan
National Hospital Organization Nagasaki Medical Center
Ohmura, Nagasaki, Japan
National Hospital Organization Osaka Minami Medical Center
Kawachinagano, Osaka, Japan
Koshigaya Municipal Hospital
Koshigaya, Saitama, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01473836     History of Changes
Other Study ID Numbers: A6831005
Study First Received: October 11, 2011
Last Updated: October 29, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
Metronidazole
intra-abdominal infection
pelvic inflammatory disease
anaerobe

Additional relevant MeSH terms:
Ceftriaxone
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 19, 2013