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

Completed
Phase of Trial: Phase I

Latest Information Update: 11 Jun 2017

At a glance

  • Drugs Solithromycin (Primary) ; Solithromycin (Primary) ; Solithromycin (Primary)
  • Indications Bacterial infections
  • Focus Pharmacokinetics
  • Sponsors Cempra Pharmaceuticals
  • Most Recent Events

    • 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.
    • 10 May 2016 This trial was discontinued in Bulgaria, according to European Clinical Trials Database record.
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