NCT02605122

Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia

A Phase 2/3, Randomized, Open-Label, Multi-center Study to Determine the Safety and Efficacy of Solithromycin in Adolescents and Children With Suspected or Confirmed Community-Acquired Bacterial Pneumonia

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Melinta Therapeutics, Inc. · Industry
• Sex: All
• Age: 2 Months – 17 Years
• Healthy volunteers: Not accepted

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 description

Subjects who meet all inclusion/exclusion criteria and sign the informed consent/assent were enrolled. Subjects were randomized to receive solithromycin or a comparator antibiotic, administered IV and/or by mouth (PO) based on weight and age. Subjects were treated daily for 5 to 7 days with oral solithromycin and 5 to 7 days with IV or IV-to-oral solithromycin. Subjects were treated for 5 to 10 days with comparator antibiotics. Subjects received safety and efficacy assessments during and after treatment.

Conditions

• Community-acquired Bacterial Pneumonia

Interventions

Type	Name	Description
DRUG	Solithromycin
DRUG	Standard of Care	Age- and weight-based dosing as appropriate per sites standard of care.

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-03-21
• Completion: 2018-03-21
• First posted: 2015-11-16
• Last updated: 2019-01-03
• Results posted: 2019-01-03

Locations

58 sites across 6 countries: United States, Bulgaria, Hungary, Philippines, Spain, United Kingdom

Regulatory

• FDA-regulated drug study