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A Phase 1, Open-label, Multi-center Study to Determine the PK and Safety of Solithromycin as Add-on Therapy in Adolescents With Suspected or Confirmed Bacterial Infection

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Trial Profile

A Phase 1, Open-label, Multi-center Study to Determine the PK and Safety of Solithromycin as Add-on Therapy in Adolescents With Suspected or Confirmed Bacterial Infection

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 08 Sep 2020

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At a glance

  • Drugs Solithromycin (Primary) ; Solithromycin (Primary)
  • Indications Bacterial infections
  • Focus Pharmacokinetics
  • Sponsors Cempra Pharmaceuticals; Melinta Therapeutics

    • Most Recent Events

    • 11 Jun 2018 Results assessing combined PK data from 2 phase I studies (NCT01966055 and NCT02268279) published in the Antimicrobial Agents and Chemotherapy
    • 17 Apr 2015 According to a Cempra Pharmaceuticals media release, results from this trial will be presented at the 2015 Pediatric Academic Societies (PAS) Annual Meeting.
    • 22 Sep 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov.

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