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Phase 1, Non-comparative, Open-label Study to Characterize the Pharmacokinetics of a Single Intravenous Dose of Ceftolozane/tazobactam in Pediatric Patients Receiving Standard of Care Antibiotic Therapy for Proven or Suspected Gram negative Infection or for Peri-operative Prophylaxis PIP decision number: P/0088/2017

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Phase 1, Non-comparative, Open-label Study to Characterize the Pharmacokinetics of a Single Intravenous Dose of Ceftolozane/tazobactam in Pediatric Patients Receiving Standard of Care Antibiotic Therapy for Proven or Suspected Gram negative Infection or for Peri-operative Prophylaxis PIP decision number: P/0088/2017

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 14 Dec 2023

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At a glance

  • Drugs Ceftolozane/tazobactam (Primary)
  • Indications Gram-negative infections
  • Focus Pharmacokinetics
  • Sponsors Cubist Pharmaceuticals

    • Most Recent Events

    • 27 Aug 2018 Results published in the Pediatric Infectious Disease Journal
    • 24 Apr 2018 Results assessing pharmacokinetics (PK) and safety of ceftolozane/tazobactam in term and premature neonates and young infants, presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases.
    • 28 Jul 2017 Status changed from recruiting to completed.

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