CABP
Research type
Research Study
Full 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 years of age) with Suspected or Confirmed Community-Acquired Bacterial Pneumonia
IRAS ID
195179
Contact name
Prakash Satodia
Contact email
Sponsor organisation
Cempra Inc
Eudract number
2014-004039-37
Duration of Study in the UK
1 years, 10 months, 5 days
Research summary
This is a clinical trial study to assess the tolerability and safety of solithromycin in adolescents and children with community-acquired bacterial pneumonia (CABP).
Community-acquired bacterial pneumonia (CABP) is a common worldwide infection in the lung In children, the microorganisms responsible for CABP differ by age and include Streptococcus pneumonia (most common cause of pneumonia in children older than 1 week of age), Streptococcus agalactiae, Chlamydia trachomatis, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Hemophilus influenzae, group A Streptococcus, Legionella, and Staphylococcus aureuas.
The World Health Organization has stated that antibiotic resistance is one of the greatest healthcare challenges for the future.
Solithromycin (CEM-101) is the investigational product from Cempra Pharmaceuticals, Inc.It is a next-generation oral and intravenous fluoroketolide which is active against macrolide-resistant bacteria and is more active than azithromycin or clarithromycin against most macrolide-susceptible bacteria. It is also the first macrolide since azithromycin to have the potential to be administered both orally and intravenously (IV).
Solithromycin was shown to be non-inferior to Moxifloxacin in an adults with CABP who could be treated orally only. However, the safety and efficacy of solithromycin have not yet been studied in pediatric subjects with CABP.
Subjects will be randomized to receive solithromycin or a comparator drug, administered intravenously (IV) or by mouth (PO) in capsules or suspension formulation based on weight and age.
The duration of subject participation from signing the informed consent form (ICF) will be approximately 40 days (including study drug administration & follow up visits post randomization. The study duration from first subject first visit until last subject last visit will be approximately 24 months.
Approximately 400 subjects (~300 in the solithromycin group and ~100 in the comparator group) will be enrolled. Randomization will be stratified by the following age groups: 1). 12-17 years of age, 2). 6- <12 years , 3). 24 months- <6 years, 4). ≥2 months to <24 months.
A minimum of 40 subjects will be included in each age group. Approximately 20% of subjects will be enrolled in the U.S.Eligible patients will undergo Pharmacokinetic sample collection.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0108
Date of REC Opinion
31 May 2016
REC opinion
Further Information Favourable Opinion