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.
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Percentage of Participants With a Favorable Clinical Response at Completion of IV Study Therapy
Timeframe: 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)
Timeframe: Up to 14 days following completion of all study therapy (up to Day 28)
Percentage of Participants With Elevated AST or ALT Laboratory Values >= 3X the ULN, Total Bilirubin >= 2X the ULN, and Alkaline Phosphatase Values < 2X the ULN
Timeframe: Up to 14 days following completion of all study therapy (up to Day 28)
Percentage of Participants With Any Adverse Event (AE)
Timeframe: Up to 14 days following completion of all study therapy (up to Day 28)
Percentage of Participants With Any Serious Adverse Event (SAE)
Timeframe: Up to 14 days following completion of all study therapy (up to Day 28)
Percentage of Participants With Any Drug-related AE
Timeframe: Up to 14 days following completion of all study therapy (up to Day 28)
Percentage of Participants With Any Drug-related SAE
Timeframe: Up to 42 days following completion of all study therapy (up to Day 56)
Percentage of Participants Who Discontinued IV Study Therapy Due to an AE
Timeframe: Up to 14 days post initiation of IV study therapy (up to 14 days)
Percentage of Participants Who Discontinued IV Study Therapy Due to a Drug-related AE
Timeframe: Up to 14 days post initiation of IV study therapy (up to 14 days)
Percentage of Participants With Specific AEs With Incidence of >= 4 Participants in One Treatment Group
Timeframe: Up to 42 days following completion of all study therapy (up to Day 56)
Percentage of Participants With Predefined Limit of Change (PDLC) With Incidence of >= 4 Participants in One Treatment Group
Timeframe: Up to 42 days following completion of all study therapy (up to Day 56)
Percentage of Participants With System Organ Class (SOC) With AEs With Incidence of >= 4 Participants in One Treatment Group
Timeframe: Up to 42 days following completion of all study therapy (up to Day 56)