Study of the Safety, Tolerability, and Efficacy of Relebactam (MK-7655) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone to Treat Complicated Intra-Abdominal Infection [cIAI] (MK-7655-004)

Intra-abdominal Infections Clinical Trial

Official title:
A Phase II, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of MK-7655 + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone in Patients With Complicated Intra-Abdominal Infection [cIAI]

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of adding 125 mg or 250 mg doses of relebactam (MK-7655) to imipenem/cilastatin in adults 18 years or older with Complicated Intra-Abdominal Infection (cIAI). The primary hypothesis is that the relebactam + imipenem/cilastatin treatment regimen is non-inferior to treatment with imipenem/cilastatin alone with respect to the percentage of participants with a favorable clinical response at completion of intravenous (IV) study therapy.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01506271
Study type	Interventional
Source	Merck Sharp & Dohme Corp.
Contact
Status	Completed
Phase	Phase 2
Start date	June 1, 2012
Completion date	August 12, 2014

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT04240288` - Procalcitonin Guided Antibiotic Therapy	N/A
Completed	`NCT01431326` - Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Completed	`NCT01473836` - A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection	Phase 3
Terminated	`NCT03354754` - LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Intra-abdominal Infection (cIAI)	Phase 2
Completed	`NCT00965848` - A Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections	Phase 4
Completed	`NCT05628493` - Gut Microbiota Analysis in IAI Patients With Sepsis-associated Liver Dysfunction
Completed	`NCT02442596` - Abdominal SepsiS Study: Epidemiology of Etiology and Outcome	N/A
Recruiting	`NCT04094818` - HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis
Withdrawn	`NCT05639504` - Sepsis Prognosis and Diagnosis in the Emergency Department (SPEED)
Completed	`NCT00827541` - Post-Authorization Study Evaluating Safety Of Tigecycline	N/A
Completed	`NCT01789905` - Tygacil Drug Use Investigation