A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection

Pfizer

Status and phase: Completed; Phase 4

Conditions: Intra-abdominal Infection

Treatments: Drug: Tigecycline; Drug: Imipenem/cilastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01721408

B1811185

Details and patient eligibility

About

This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin in hospitalized patients with a complicated intra-abdominal infection.

Enrollment: 470 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hospitalized male or female subjects, at least 18 year of age.
• Complicated intra-abdominal infection is present at most under two weeks duration.
• Minimal clinical criteria at the time of intra-abdominal infection diagnosis or highly suspected intra-abdominal infection.

Exclusion criteria

• Anticipated length of antibiotic therapy less than 5 days or the likelihood that the subject will not complete the course of treatment.
• Intra-abdominal infection known to be caused by 1 or more bacterial pathogens not susceptible to both of the study drugs.
• Had accepted non-study antibiotics more than 24 hr within 72 hrs before enrollment except for subjects declared prior failures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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470 participants in 2 patient groups

Group A

Experimental group

Treatment:

Drug: Tigecycline

Group B

Active Comparator group

Treatment:

Drug: Imipenem/cilastatin