At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Estimate the Efficacy and Safety of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium + Imipenem/Cilastatin in Subjects With Imipenem-Resistant Bacterial Infection
In Brief
A Phase 3 clinical trial evaluating Imipenem+Cilastatin/Relebactam, Colistimethate sodium (CMS), and 2 other interventions for Bacterial Infections. Completed, enrolled 50 participants.
Detailed Summary
The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (MK-7655A) versus colistimethate sodium+imipenem+cilastatin in the treatment of imipenem-resistant bacterial infections. Infections evaluated in the study will be hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated intra-abdominal infection (cIAI), and complicated urinary tract infection (cUTI).
Study Details
Timeline
Interventions
Imipenem+Cilastatin/Relebactam 200/100 mg to 500/250 mg, depending on renal function, IV infusion once every 6 hours
Colistimethate base activity 300 mg (\~720 mg CMS) IV infusion loading dose, followed by colistimethate base activity 75 mg to 150 mg (\~180 to 360 mg CMS), depending on renal function, once every 12 hours
Imipenem+cilastatin 200 mg to 500 mg, depending on renal function, IV infusion once every 6 hours
Placebo to CMS IV infusion once every 12 hours