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

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-21

Study Completion Date

2017-09-18

Brief Summary

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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).

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Detailed Description

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Conditions

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Bacterial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1: Imipenem+Cilastatin/Relebactam

Participants will be stratified by infection type (HABP/VABP, cIAI, and cUTI) and randomized to receive imipenem+cilastatin/relebactam intravenous (IV) infusion once every 6 hours and placebo for colistimethate sodium IV infusion once every 12 hours for 5 to 21 days for cIAI and cUTI or for 7 to 21 days for HABP or VABP. Treatment durations \>21 days may be approved by the Sponsor for participants requiring longer treatment duration.

Group Type EXPERIMENTAL

Imipenem+Cilastatin/Relebactam

Intervention Type DRUG

Imipenem+Cilastatin/Relebactam 200/100 mg to 500/250 mg, depending on renal function, IV infusion once every 6 hours

Placebo to CMS

Intervention Type DRUG

Placebo to CMS IV infusion once every 12 hours

Group 2: Colistimethate sodium + Imipenem+Cilastatin

Participants will be stratified by infection type (HABP/VABP, cIAI, and cUTI) and randomized to receive colistimethate sodium IV infusion once every 12 hours and imipenem+cilastatin IV infusion once every 6 hours for 5 to 21 days for cIAI and cUTI or for 7 to 21 days for HABP or VABP. Treatment durations \>21 days may be approved by the Sponsor for participants requiring longer treatment duration.

Group Type ACTIVE_COMPARATOR

Colistimethate sodium (CMS)

Intervention Type DRUG

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

Intervention Type DRUG

Imipenem+cilastatin 200 mg to 500 mg, depending on renal function, IV infusion once every 6 hours

Group 3: Imipenem+Cilastatin/Relebactam

Participants with documented imipenem-resistant and colistin-resistant bacterial infections may be eligible to receive open-label imipenem+cilastatin/relebactam IV infusion once every 6 hours for 5 to 21 days for cIAI and cUTI or for 7 to 21 days for HABP or VABP. Treatment durations \>21 days may be approved by the Sponsor for participants requiring longer treatment duration.

Group Type EXPERIMENTAL

Imipenem+Cilastatin/Relebactam

Intervention Type DRUG

Imipenem+Cilastatin/Relebactam 200/100 mg to 500/250 mg, depending on renal function, IV infusion once every 6 hours

Interventions

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Imipenem+Cilastatin/Relebactam

Imipenem+Cilastatin/Relebactam 200/100 mg to 500/250 mg, depending on renal function, IV infusion once every 6 hours

Intervention Type DRUG

Colistimethate sodium (CMS)

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

Intervention Type DRUG

Imipenem+Cilastatin

Imipenem+cilastatin 200 mg to 500 mg, depending on renal function, IV infusion once every 6 hours

Intervention Type DRUG

Placebo to CMS

Placebo to CMS IV infusion once every 12 hours

Intervention Type DRUG

Other Intervention Names

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MK-7655A

Eligibility Criteria

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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 (endocarditis, osteomyelitis, meningitis, prosthetic joint infection, disseminated fungal infection, or active pulmonary tuberculosis) 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No