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 INFECTIO

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 1 人开始时间: 2015年9月16日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•Treatment group 1, 2 and 3:
•1 Be ≥ 18 years of age on the day of signing ICF.
•2 Require hospitalization and treatment with IV antibiotic therapy for a new, persistent or progressing bacterial infection
•3 Has positive culture data obtained from the primary infection-site specimen collected within 1 week of study entry and at least one of the suspected causative pathogen(s) from that specimen meets all of criteria stablished for each Treatment Group.
•4 Agree to allow any bacterial isolates obtained from protocol-required specimens related to the current infection to be provided the Central Microbiology Reference Laboratory for study-related microbiological testing, long-term storage, and other future testing.
•5 Understand (or have a legal representative that understands) the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent for the trial.
•6 Meet one of the following categories:
•a The subject is a male who is not of reproductive potential.
•b The subject is a female who is not of reproductive potential.
•c The subject is a female or a male who is of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner from the time of consent through completion of the study.

•Treatment group 1, 2 and 3:
•1 APACHE II score >30*
•2 Infection caused by specified bacteria
•3 Concurrent infection that would interfere with evaluation of response to the antibiotics
•4 Received any form of systemic colistin for > 2 h within the 72h immediately prior to initiation of therapy
•5 HABP/VABP caused by an obstructive process
•6 cUTI which meets the stablished conditions
•7 Serious allergy, hypersensitivity, or any serious reaction to the specified medications
•8 Pregnant or is expecting to conceive (or is a male partner of a female who is expecting to conceive), is breastfeeding, or plans to breastfeed prior to completion of the study
•9 Seizure disorder, myasthenia gravis*, porphyria*, cystic fibrosis*, granulomatous disease*
•10 Is anticipated to be treated with any of the specified medications
•11 Estimated or actual creatinine clearance less than 15 mL/min
•12 Hemodialysis
•13 History or evidence of any circumstance that, in the opinion of the investigator, might confound the results, interfere with the subject’s participation, or pose additional risk in administering the study drugs
•14 Is currently participating in, or has participated in, any other clinical study involving the administration of investigational or experimental medication
•15 Immediate family member who is investigational site or sponsor staff
•16 Previously participated in this study
•* Criteria applies only to treatment Group 1 and 2

发起方

MERCK SHARP & DOHME PERU S.R.L.,