Efficacy and Safety of Imipenem+Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium + Imipenem+Cilastatin in Imipenem-Resistant Bacterial Infection (MK-7655A-013)



Status:Recruiting
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:8/10/2017
Start Date:August 21, 2015
End Date:September 29, 2017
Contact:Toll Free Number
Phone:1-888-577-8839

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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

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).


Inclusion Criteria:

- Hospitalization that requires treatment with IV antibiotic therapy for a new,
persistent or progressing bacterial infection involving at least 1 of 3 primary
infection types (HABP, VABP, cIAI, or cUTI)

- Positive culture data from the primary infection-site specimen collected within 1 week
of study entry. At least one of the suspected causative pathogens from the specimen
meets all of the following: 1) identified as a Gram-negative bacterium, 2)
culture-confirmed imipenem resistance (and colistin resistance for Group 3 only), 3)
culture-confirmed susceptibility to imipenem/relebactam and to colistin (for Groups 1
and 2 only)

- Not of reproductive potential, or of reproductive potential and agrees to avoid
becoming pregnant or impregnating a partner by complying with one of the following: 1)
practice abstinence, or 2) use of acceptable contraception during heterosexual
activity

Exclusion Criteria:

- Concurrent infection that would interfere with evaluation of the response to the study
antibiotics

- Received treatment with any form of systemic colistin for >24 hours within 72 hours
before initiation of study drug (for Groups 1 and 2 only)

- HABP or VABP caused by an obstructive process

- cUTI which meets any of the following: 1) complete obstruction of any portion of the
urinary tract, 2) known ileal loop, 3) intractable vesico-ureteral reflux, 4) presence
of an indwelling urinary catheter which cannot be removed at study entry

- History of serious allergy, hypersensitivity, or any serious reaction to listed
antibiotics (per-protocol)

- Female who is pregnant or is expecting to conceive (or a male partner of a female who
is expecting to conceive), is breastfeeding, or plans to breastfeed before completion
of the study

- Anticipated treatment with any of the following during the study: valproic acid or
divalproex sodium, or concomitant systemic (e.g. IV, oral or inhaled) antimicrobial
agents with known Gram-negative bacterial coverage

- Currently undergoing hemodialysis or peritoneal dialysis

- Participated or anticipates participating in any other clinical study involving
administration of investigational medication up to 30 days before screening or during
the course of the trial

- Concurrent endocarditis, osteomyelitis, meningitis, prosthetic joint infection,
disseminated fungal infection, or active pulmonary tuberculosis
We found this trial at
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Sao Paulo,
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