CompletedPhase 4

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

Australia, China, Denmark473 participantsStarted 2005-10

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours. * Fever plus other symptoms such as nausea, vomiting, abdominal pain. Exclusion Criteria: * Cancer * Medicines that suppress the immune system * Dialysis

What they're measuring

Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit

Timeframe: up to 6 weeks

Trial details

NCT IDNCT00230971

SponsorWyeth is now a wholly owned subsidiary of Pfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-09

Results submitted2009-09-30

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