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

Trial Profile

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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 Apr 2019

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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
    • 13 Nov 2016 Status changed from recruiting to completed.
    • 12 Sep 2016 Planned primary completion date changed from 1 Aug 2016 to 1 Oct 2016.
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