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

Phase 4 Completed 470 enrolled Pfizer

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2012-11
Primary completion: 2015-10
Completion: 2015-10

Outcome

Met primary endpoint

paper Tigecycline was non-inferior to imipenem/cilastatin with respect to clinical response at TOC for all CE subjects PMID 30584308 ↗

registry analysis (non-inferiority or equivalence test); Tigecycline 50mg vs Imipenem/Cilastatin; p = 0.0008; Difference in percentage -6.7 (95% CI -12.0 to -1.4); See method of CI NCT01721408 ↗

registry analysis (non-inferiority or equivalence test); Tigecycline 50mg vs Imipenem/Cilastatin; p = 0.0040; Difference in percentage -6.0 (95% CI -12.8 to 0.8); See method of CI NCT01721408 ↗

Publications

Chen Y, Zhu D, Zhang Y, Zhao Y, Chen G, Li P, Xu L, Yan P, Hickman MA, Xu X, Tawadrous M, Wible M. 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 in China. Ther Clin Risk Manag. 2018 Nov 30;14:2327-2339. doi: 10.2147/TCRM.S171821. eCollection 2018.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cilastatin	Small molecule	500 mg	Intravenous
Comparator	IMIPENEM ANHYDROUS	Small molecule	500 mg	Intravenous
Subject	Tigecycline	Small molecule	50 mg	Intravenous