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A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia

Trial Profile

A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Apr 2019

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At a glance

  • Drugs Solithromycin (Primary) ; Solithromycin (Primary) ; Moxifloxacin; Moxifloxacin
  • Indications Bacterial infections; Community-acquired pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms SOLITAIRE-IV
  • Sponsors Cempra Pharmaceuticals; Melinta Therapeutics
  • Most Recent Events

    • 25 Apr 2017 Results of subgroup analysis of two phase III studies (NCT01756339 and NCT01968733) assessing response by geographical region, presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases.
    • 25 Apr 2017 Results of pooled analysis (n=785) assessing early clinical response from two phase III studies (NCT01756339 and NCT01968733) in microbiologically positive subjects, presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases.
    • 25 Apr 2017 Results of comparative efficacy across patient age subpopulations data from two phase III study (SOLITAIRE-Oral and SOLITAIRE-IV) presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases
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