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

NCT02605122 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2019-01-03

Study results available
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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).

Conditions

  • Community-acquired Bacterial Pneumonia

Interventions

DRUG

Solithromycin

DRUG

Standard of Care

Age- and weight-based dosing as appropriate per sites standard of care.

Sponsors & Collaborators

Principal Investigators

  • Michael Cohen-Wolkowiez, MD, PhD · Duke Clinical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-03-21
Completion
2018-03-21
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Hungary
  • Philippines
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02605122 on ClinicalTrials.gov