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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of MK-7655 + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone in Patients With C

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

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • Percentage of participants with a favorable clinical response at completion of IV study therapy [ Time Frame: 4 to 14 days post initiation of intravenous (IV) study therapy (up to postrandomization day 14) ]
  • Percentage of participants with an elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory values that are greater than or equal to 5X the upper limit of normal (ULN) [ Time Frame: Up to 14 days following completion of all study therapy ]
  • Percentage of participants with elevated AST or ALT laboratory values that are greater than or equal to 3X the ULN, as well as elevated total bilirubin greater than or equal to 2X the ULN, and alkaline phosphatase values that are less than 2X the ULN [ Time Frame: Up to 14 days following completion of all study therapy ]
  • Percentage of participants with any adverse event (AE) [ Time Frame: Up to 14 days following completion of all study therapy ]
  • Percentage of participants with any serious adverse event (SAE) [ Time Frame: Up to 42 days following completion of all study therapy ]
  • Percentage of participants with any drug-related AE [ Time Frame: Up to 14 days following completion of all study therapy ]
  • Percentage of participants with any SAE and drug-related AE [ Time Frame: Up to 42 days following completion of all study therapy ]
  • Percentage of participants who discontinued IV study therapy due to an AE [ Time Frame: Up to 14 days post initiation of IV study therapy ]
  • Percentage of participants who dis

    Original Primary Outcome: Proportion of patients with a favorable clinical response at completion of IV study therapy [ Time Frame: 4 to 14 days post initiation of intravenous (IV) study therapy ]

    Current Secondary Outcome:

    • Percentage of participants with a favorable clinical response at completion of IV study therapy in participants who have imipenem-resistant, gram-negative cIAI infections. [ Time Frame: 4 to 14 days post initiation of IV study therapy (up to postrandomization day 14). ]
    • Percentage of participants with a favorable clinical response at early follow-up [ Time Frame: Up to 9 days following completion of all study therapy ]
    • Percentage of participants with a favorable microbiological response at completion of IV study therapy [ Time Frame: Up to 14 days post initiation of IV study therapy (up to postrandomization day 14) ]
    • Percentage of participants with a favorable microbiological response at early follow-up [ Time Frame: Up to 9 days following completion of all study therapy ]
    • Percentage of participants with a favorable clinical response at late follow-up [ Time Frame: Up to 42 days following completion of all study therapy ]
    • Percentage of participants with a favorable microbiological response at late follow-up [ Time Frame: Up to 42 days following completion of all study therapy ]


    Original Secondary Outcome: Proportion of patients with a favorable clinical response at completion of IV study therapy in patients who have imipenem-resistant, gram-negative cIAI infections. [ Time Frame: 4 to 14 days post initiation of intravenous (IV) study therapy. ]

    Information By: Merck Sharp & Dohme Corp.

    Dates:
    Date Received: January 5, 2012
    Date Started: June 2012
    Date Completion:
    Last Updated: November 3, 2016
    Last Verified: November 2016