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A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CEFTAZIDIME AND AVIBACTAM IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 3 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT

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Trial Profile

A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CEFTAZIDIME AND AVIBACTAM IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 3 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 28 Mar 2024

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At a glance

  • Drugs Avibactam/ceftazidime (Primary)
  • Indications Bacterial infections; Gram-negative infections
  • Focus Adverse reactions; Pharmacokinetics
  • Acronyms NOOR
  • Sponsors Pfizer

Most Recent Events

  • 09 Jan 2023 Status changed from recruiting to discontinued.
  • 19 Dec 2022 This trial has been completed in Hungary and Slovakia according to European Clinical Trials Database record.
  • 19 Dec 2022 This trial has been completed in Estonia (End Date: 18 Nov 2022) according to European Clinical Trials Database record.

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