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A Phase 2/3 Open-label, Randomized, Active-controlled Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of MK-7655A in Pediatric Participants From Birth to Less Than 18 Years of Age With Confirmed or Suspected Gram-negative Bacterial Infection

Trial Profile

A Phase 2/3 Open-label, Randomized, Active-controlled Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of MK-7655A in Pediatric Participants From Birth to Less Than 18 Years of Age With Confirmed or Suspected Gram-negative Bacterial Infection

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 30 Aug 2024

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At a glance

  • Drugs Cilastatin/imipenem/relebactam (Primary) ; Amoxicillin; Amoxicillin/clavulanic acid; Antibacterials; Antibacterials; Cefaclor; Cefepime; Cefixime; Cefotaxime; Cefoxitin; Cefpodoxime proxetil; Ceftazidime; Ceftibuten; Ceftriaxone; Cefuroxime; Cefuroxime axetil; Ciprofloxacin; Ciprofloxacin; Cotrimoxazole; Delafloxacin; Gentamicin; Gentamicin; Imipenem/cilastatin; Levofloxacin; Levofloxacin; Meropenem; Metronidazole; Metronidazole; Moxifloxacin; Nitrofurans; Nitrofurantoin; Norfloxacin; Ofloxacin; Piperacillin/tazobactam; Sulfamethoxazole; Trimethoprim
  • Indications Gram-negative infections; Intra-abdominal infections; Nosocomial pneumonia; Urinary tract infections; Ventilator associated pneumonia
  • Focus Adverse reactions; Registrational
  • Sponsors Merck Sharp & Dohme Corp.
  • Most Recent Events

    • 03 Jul 2024 This study has been Completed in Bulgaria, According to European Clinical Trials Database record.
    • 27 May 2024 Status changed from active, no longer recruiting to completed.
    • 21 May 2024 This study has been Completed in Estonia, According to European Clinical Trials Database record.

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