Clinical Trial Details

NCT ID: NCT02493764
Date Last Changed: August 29, 2017

Overview

Research Study Summary

A clinical research study for the treatment of Bacterial Pneumonia (MK-7655A-014)

Research Study 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

Purpose

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.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Merck Sharp & Dohme Corp.
Duration
42 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

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

Site Locations (29)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35249 Call for Information (Investigational Site 0514)
United States California Sacramento 95817 Call for Information (Investigational Site 0512)
United States Florida Miami 33136 Call for Information (Investigational Site 0504)
United States Illinois Chicago 60611 Call for Information (Investigational Site 0518)
United States Iowa Iowa City 52242 Call for Information (Investigational Site 0522)
United States Massachusetts Boston 02115 Call for Information (Investigational Site 0524)
United States Michigan Detroit 48202 Call for Information (Investigational Site 0500)
United States Nevada Las Vegas 89109 Call for Information (Investigational Site 0506)
United States Ohio Columbus 43210 Call for Information (Investigational Site 0529)
United States Pennsylvania Philadelphia 19141 Call for Information (Investigational Site 0525)
Argentina Buenos Aires Merck Sharp & Dohme (Argentina) Inc.
Alfredo Wilkinson
54 11 4796 8200
Brazil Sao Paulo MSD Brasil
MSD Online
0800 012 22 32
Bulgaria Sofia Merck Sharp & Dohme Bulgaria EOOD
Eran Gefen
38 (044) 393 74 80
Canada Quebec Kirkland H9H 4M7 Merck Canada
Medical Information Centre Centre d'information medicale Merck Canada Inc.
514-428-8600 / 1-800-567-2594
Colombia Bogota MDS Colombia SAS
Francesca Carvajal
57 1219109011090
Estonia Tallinn Merck Sharp & Dohme OU
Katrin Moeschlin
+46 (0) 8ý578ý135 00
France Paris MSD France
Dominique Blazy
33 147548990
Germany Haar MSD Sharp & Dohme GmbH
German Medical Information Center
49 800 673 673 673
Guatemala Guatemala MSD CARD
Soraya Cedraro
507-282-7200
Italy Rome MSD Italia S.r.l.
Patrizia Nardini
39 06 361911
Japan Chiyoda-Ku, Tokyo 102-8667 MSD K.K.
Japan Call Center
81-3-6272-1957
Korea, Republic of Seoul 4130 MSD Korea LTD
Jongho Ahn
82-2-331-2000 2015
Latvia Riga Merck Sharp & Dohme Latvija SIA
Katrin Moeschlin
+46 (0) 8ý578ý135 00
Mexico Mexico City MSD
Juan Marques
52 55254819608
Philippines Makati Merck Sharp & Dohme (I.A.) Corporation
Cesar Recto
632 784 9500
Portugal Paco Darcos Merck Sharp & Dohme Lda.
Ana Maria Nogueira
351-21-4465890
Romania Bucharest Merck Sharp & Dohme Romania SRL
Simona Olaru
38 (044) 393 74 80
Russian Federation Moscow Merck Sharp & Dohme IDEA, Inc.
Tatiana Serebriakova
74959167100, EXT.366
Ukraine Kiev MSD Ukraine LLC
Eran Gefen
38 (044) 393 74 80

Contact

Toll Free Number
1-888-577-8839

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