Study of the Safety, Tolerability, and Efficacy of Relebactam (MK-7655) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone to Treat Complicated Intra-Abdominal Infection [cIAI] (MK-7655-004)

• Status: Completed
• Trial end date: 2014-08-12
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of adding 125 mg or 250 mg doses of relebactam (MK-7655) to imipenem/cilastatin in adults 18 years or older with Complicated Intra-Abdominal Infection (cIAI). The primary hypothesis is that the relebactam + imipenem/cilastatin treatment regimen is non-inferior to treatment with imipenem/cilastatin alone with respect to the percentage of participants with a favorable clinical response at completion of intravenous (IV) study therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Cilastatin; Imipenem; MK-7655; Relebactam

Criteria

Inclusion Criteria:

• Clinically suspected and/or bacteriologically documented cIAI requiring hospitalization and treatment with IV antibiotic therapy.

• Enrolled intraoperatively or postoperatively on the basis of operative findings OR enrolled preoperatively on the basis of compelling preoperative clinical findings.

Exclusion Criteria:

• Infection which should be managed by Staged Abdominal Repair (STAR) or open abdomen technique.

• Acute Physiology and Chronic Health Evaluation II (APACHE II) score greater than 30.

• Any amount of effective antibiotic therapy after obtaining the culture for admission to this study and prior to the administration of the first dose of IV study therapy.

• An infection which has been treated with >24 hours of systemic antibiotic therapy known to be effective against the presumed or documented etiologic pathogen(s) within the 72-hour period immediately prior to consideration for entry into the study.

• History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to carbapenem antibiotics, any cephalosporins, penicillins, or other β-lactam agents.

• History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to other β-lactamase inhibitors (e.g., tazobactam, sulbactam, clavulanic acid).

• History of a seizure disorder (requiring ongoing treatment with anticonvulsive therapy or prior treatment with anti-convulsive therapy in the last 3 years).

• Currently being treated with valproic acid or has used valproic acid in the 2 weeks prior to screening.

• Rapidly progressive or terminal illness (unlikely to survive the approximately 6- to 8-week study period).

• Pregnant or expecting to conceive, breastfeeding, or plans to breast feed within 1 month of completion of the study.

• Participant in whom a response to IV study therapy within the timeframe of treatment specified in this protocol is considered unlikely.

• Concurrent infection that would interfere with evaluation of response to the study antibiotics.

• Need for concomitant systemic antimicrobial agents in addition to those designated in the various study treatment groups.

• cIAI due to a confirmed fungal pathogen.

• Currently receiving immunosuppressive therapy, including use of high-dose corticosteroids.

• Prior recipient of a renal transplantation.

• Estimated or actual creatinine clearance of <50 mL/minute.

• History of any other illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drug to the patient.

• Laboratory abnormalities as specified in protocol.

• Currently participating in, or has participated in any other clinical study involving the administration of investigational or experimental medication (not licensed by regulatory agencies) at the time of presentation or during the previous 30 days prior to screening or is anticipated to participate in such a clinical study during the course of the trial.