Clinical Trial: Safety and Efficacy of Solithromycin in Adolescents and Children With Community-acquired Bacterial Pneumonia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

Brief Summary: This is a phase 2/3, randomized, open-label, active control, multi-center study to assess the safety and efficacy of solithromycin in children and adolescents with community-acquired bacterial pneumonia (CABP).

Detailed Summary:
Sponsor: Cempra Inc

Current Primary Outcome: Incidence of treatment-emergent adverse events [safety and tolerability] of solithromycin in adolescents and children with community-acquired bacterial pneumonia (CABP) [ Time Frame: Up to 30 days post-treatment ]

Incidence of adverse events, laboratory abnormalities, vital signs, and physical exam changes will be summarized.


Original Primary Outcome: Same as current

Current Secondary Outcome: Success rates at the end of therapy [efficacy] of solithromycin in adolescents and children with CABP [ Time Frame: up to 14 days post-treatment ]

End-of-treatment assessment, early clinical response (Day 2 to 4), and short-term follow-up visit clinical success rates will be summarized.


Original Secondary Outcome: Same as current

Information By: Cempra Inc

Dates:
Date Received: November 10, 2015
Date Started: April 2016
Date Completion: February 2018
Last Updated: March 17, 2017
Last Verified: March 2017