Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With … (NCT02493764) | Clinical Trial Compass
CompletedPhase 3
Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014)
537 participantsStarted 2015-11-24
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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 sy…
What they're measuring
1
Percentage of Participants With All-cause Mortality (ACM) Through Day 28 in the Modified Intention-to-treat (MITT) Population