NCT01721408

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

A Multicenter, Double-blind, Randomized, Comparison Study Of The Efficacy And Safety Of Tigecycline To Imipenem/Cilastatin To Treat Complicated Intra-abdominal Infections In Hospitalized Subjects.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 470 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Intra-abdominal Infection

Interventions

Type	Name	Description
DRUG	Tigecycline	every 12 hours (an initial intravenous dose of 100 mg followed by 50 mg twice a day approximately every 12 hours) and placebo intravenous doses every 12 hours beginning 6 hours after the initial intravenous dose of tigecycline for at least for 5 days and up to 14 days.
DRUG	Imipenem/cilastatin	every 6 hours intravenously, and the imipenem/cilastatin will be dosed by 500mg/500mg for the subjects with creatinine clearance equal or above 71ml/min/1.73m2 or dose will be adjusted by Schedule of Study Drug Administration for Subjects with Renal Impairment.

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2012-11-05
• Last updated: 2018-04-09
• Results posted: 2018-04-09

Locations

47 sites across 1 country: China