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
- Conditions
- -A488 Other specified bacterial diseasesOther specified bacterial diseasesA488
- Registration Number
- PER-026-15
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method