Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

537 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-24

Study Completion Date

2019-04-03

Brief Summary

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This study aims to compare treatment with a fixed-dose combination (FDC) of imipenem/relebactam/cilastatin (IMI/REL) with a FDC of piperacillin/tazobactam (PIP/TAZ) in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VAPB, respectively). The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ in the incidence rate of all-cause mortality.

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Detailed Description

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Conditions

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Bacterial Pneumonia

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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IMI/REL

Imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered intravenously (IV) every 6 hours for a minimum of 7 days, up to 14 days. At study entry open label linezolid 600 mg will also be administered by IV every 12 hours for up to 14 days.

Group Type EXPERIMENTAL

Imipenem

Intervention Type DRUG

Imipenem 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days

Relebactam

Intervention Type DRUG

Relebactam 250 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days

Cilastatin

Intervention Type DRUG

Cilastatin 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days

Linezolid

Intervention Type DRUG

Linezolid 600 mg administered open-label by IV every 12 hours for up to 14 days

PIP/TAZ

Piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At study entry open label linezolid 600 mg will also be administered by IV every 12 hours for up to 14 days.

Group Type ACTIVE_COMPARATOR

Piperacillin

Intervention Type DRUG

Piperacillin 4000 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days

Tazobactam

Intervention Type DRUG

Tazobactam 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days

Linezolid

Intervention Type DRUG

Linezolid 600 mg administered open-label by IV every 12 hours for up to 14 days

Interventions

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Imipenem

Imipenem 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days

Intervention Type DRUG

Relebactam

Relebactam 250 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days

Intervention Type DRUG

Cilastatin

Cilastatin 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days

Intervention Type DRUG

Piperacillin

Piperacillin 4000 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days

Intervention Type DRUG

Tazobactam

Tazobactam 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days

Intervention Type DRUG

Linezolid

Linezolid 600 mg administered open-label by IV every 12 hours for up to 14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Requires treatment with IV antibiotic therapy for hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP)
* Fulfills clinical and radiographic criteria, with onset of criteria occurring after more than 48 hours of hospitalization or within 7 days after discharge from a hospital (for HABP); or at least 48 hours after mechanical ventilation (for VABP)
* Has an adequate baseline lower respiratory tract specimen obtained for Gram stain and culture
* Has an infection known or thought to be caused by microorganisms susceptible to the IV study therapy
* Agrees to allow any bacterial isolates obtained from protocol-required specimens related to the current infection to be provided to the Central Microbiology Reference Laboratory for study-related microbiological testing, long term storage, and other future testing
* Is not of reproductive potential; or if of reproductive potential agrees to avoid impregnating a partner or avoid becoming pregnant, by practicing abstinence or using acceptable contraception

Exclusion Criteria

* Has a baseline lower respiratory tract specimen Gram stain that shows the presence of Gram-positive cocci only
* Has confirmed or suspected community-acquired bacterial pneumonia (CABP)
* Has confirmed or suspected pneumonia of viral, fungal or parasitic origin
* Has HABP/VABP caused by an obstructive process, including lung cancer or other known obstruction
* Has a carcinoid tumor or carcinoid syndrome
* Has active immunosuppression defined as either receiving immunosuppressive medications or having a medical condition associated with immunodeficiency
* Is expected to survive for less than 72 hours
* Has a concurrent condition or infection that would preclude evaluation of therapeutic response
* Has received effective antibacterial drug therapy for the index infection of HABP/VABP for more than 24 hours continuously, during the previous 72 hours
* Has a history of serious allergy, hypersensitivity or a serious reaction to any penicillin or beta-lactamase inhibitors
* Female is pregnant, expecting to conceive, is breastfeeding or plans to breastfeed
* Has a history of seizure disorder requiring ongoing prior treatment with anti-convulsive therapy within the last 3 years
* Anticipates treatment with the following: valproic acid or divalproex sodium, serotonin re-uptake inhibitors, tricyclic antidepressants, or serotonin receptor antagonists, meperidine, buspirone, concomitant systemic antibacterial agents, antifungal or antiviral therapy for the index infection of HABP/VABP
* Is currently undergoing hemodialysis or peritoneal dialysis
* Is currently participating in, has participated in during the previous 30 days, or anticipates to participate in any other clinical study involving the administration of experimental medication
* Has previously participated in this study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No