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

Community-acquired Bacterial Pneumonia Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Community-acquired Bacterial Pneumonia
Pneumonia
Pneumonia, Bacterial

Clinical Trial Details

NCT number	NCT02605122
Study type	Interventional
Source	Cempra Inc
Contact
Status	Terminated
Phase	Phase 2/Phase 3
Start date	April 2016
Completion date	March 21, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01968733` - Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia	Phase 3
Recruiting	`NCT06162286` - A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP	Phase 3
Completed	`NCT01072539` - Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment
Completed	`NCT01756339` - Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia	Phase 3
Completed	`NCT01371838` - A Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia	Phase 3
Completed	`NCT01168713` - Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia	Phase 2