A Phase 2/3, Randomized, Open-Label, Multi-center Study to Determine the Safety and Efficacy of Solithromycin in Adolescents (12 to 17 Years of Age, Inclusive) and Children (≥2 Months to <12 Years of Age) With Suspected or Confirmed Community-Acquired Bacterial Pneumonia

Trial Profile

A Phase 2/3, Randomized, Open-Label, Multi-center Study to Determine the Safety and Efficacy of Solithromycin in Adolescents (12 to 17 Years of Age, Inclusive) and Children (≥2 Months to <12 Years of Age) With Suspected or Confirmed Community-Acquired Bacterial Pneumonia

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 09 Sep 2017

At a glance

  • Drugs Solithromycin (Primary) ; Solithromycin (Primary) ; Solithromycin (Primary)
  • Indications Bacterial infections; Community-acquired pneumonia
  • Focus Adverse reactions; Registrational
  • Sponsors Cempra Pharmaceuticals
  • Most Recent Events

    • 07 Jun 2017 Planned End Date changed from 1 Feb 2018 to 1 Dec 2018.
    • 07 Jun 2017 Planned primary completion date changed from 1 Feb 2018 to 1 Dec 2018.
    • 17 Mar 2017 Planned End Date changed from 1 Jan 2018 to 1 Feb 2018.
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