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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Pneumonia

Intervention: Imipenem (Drug); Relebactam (Drug); Cilastatin (Drug); Piperacillin (Drug); Tazobactam (Drug); Linezolid (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

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

Clinical Details

Official title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects With Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome: Percentage of participants surviving at Day 28

Secondary outcome: Percentage of participants with a favorable clinical response at early follow up visit

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 hour 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

Locations and Contacts

Additional Information

Starting date: October 2015
Last updated: August 11, 2015

Page last updated: August 23, 2015

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