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Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)

NCT00230971 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 473

Last updated 2013-02-25

Study results available
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Summary

This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).

Conditions

  • Appendicitis
  • Cholecystitis
  • Diverticulitis
  • Intra-Abdominal Abscess
  • Intra-Abdominal Infection
  • Peritonitis

Interventions

DRUG

tigecycline

every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)

DRUG

ceftriaxone plus metronidazole

Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Australia
  • China
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hong Kong
  • India
  • Italy
  • Philippines
  • Portugal
  • Saudi Arabia
  • South Africa
  • Spain
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00230971 on ClinicalTrials.gov