Efficacy and Safety of Imipenem+Cilastatin/Relebactam (MK-7655A) in Japanese Participants With Complicated Intra-abdominal Infection or Complicated Urinary Tract Infection (MK-7655A-017)
Condition: Complicated Intra-abdominal Infection; Complicated Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Intraabdominal Infections
Intervention: Imipenem+Cilastatin/Relebactam
Intervention description: Imipenem+Cilastatin/Relebactam 200/100 mg to 500/250 mg, depending on renal function, 30-minute IV infusion once every 6 hours
Intervention MeSH terms: Imipenem; Relebactam; Cilastatin, Imipenem Drug Combination; Cilastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (IMI/REL,
      MK-7655A) in Japanese participants with complicated intra-abdominal infection (cIAI) or
      complicated urinary tract infection (cUTI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  requires hospitalization and treatment with IV antibiotic therapy for complicated
             intraabdominal infection (cIAI) or complicated urinary tract infection (cUTI).
             Per-protocol diagnostic criteria apply to the qualifying infection types.

          -  infection is known or thought to be caused by microorganisms susceptible to the IV
             study therapy

          -  baseline specimen for primary infection site culture obtained at operative procedure
             in Screening period or at Baseline for cIAI participants, and within 48 hours before
             initiation of IV study drug for cUTI participants

          -  female or male who is not of reproductive potential, or female or male who is of
             reproductive potential and agrees to avoid becoming pregnant or impregnating a partner
             from the time of consent through completion of the study, by practicing abstinence
             from heterosexual activity or using acceptable contraception during heterosexual
             activity.

        Exclusion Criteria:

          -  received any amount of effective antibiotic therapy after obtaining the culture for
             admission to the study and before administration of the first dose of IV study therapy

          -  received treatment with systemic effective antibiotics for >24 hours within the 72
             hours before initiation of study therapy

          -  has a concurrent infection, including endocarditis, osteomyelitis, meningitis, or
             prosthetic joint infection, that would interfere with evaluation of response to
             IMI/REL

          -  has a cIAI or cUTI due to a confirmed fungal pathogen

          -  has a cUTI that meets any of the following: 1) complete obstruction of any portion of
             the urinary tract, 2) known ileal loop, 3) intractable vesico-ureteral reflux, 4)
             presence of indwelling urinary catheter which cannot be removed at study entry

          -  has a cIAI that meets any of the following: 1) infection that should be managed by
             Staged Abdominal Repair (STAR) or open abdomen therapy, 2) infection limited to the
             hollow viscus

          -  history of serious allergy, hypersensitivity, or any serious reaction to any
             carbapenem, cephalosporin, penicillin or other beta-lactam agent, or other
             beta-lactamase inhibitors

          -  female who is pregnant or is expecting to conceive, is breastfeeding, or plans to
             breastfeed before completion of the study

          -  history of a seizure disorder

          -  anticipates to be treated with valproic acid, concomitant IV or an oral antimicrobial
             considered effective to the index pathogen, in addition to the study treatment

          -  is receiving immunosuppressive therapy, including high-dose corticosteroids

          -  is undergoing hemodialysis or peritoneal dialysis

          -  participated in any other clinical study involving an investigational or experimental
             medication during the previous 30 days before Screening.