Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia
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|ClinicalTrials.gov Identifier: NCT02605122|
Recruitment Status : Terminated (Development not proceeding)
First Posted : November 16, 2015
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Community-acquired Bacterial Pneumonia||Drug: Solithromycin Drug: Standard of Care||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||A healthcare provider designated as a sub-investigator blinded to treatment allocation at the site documented clinical response at specified time points during the study.|
|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|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||March 21, 2018|
|Actual Study Completion Date :||March 21, 2018|
Solithromycin will be administered orally, as capsules or as a suspension, or intravenously. Patients may receive intravenous therapy initially and switch to an oral formulation. Dosage is weight based and age based.
Other Name: CEM-101
Active Comparator: Standard of Care
Comparators will be selected according to subject age and are consistent with current recommendations for treatment of CABP in children. These include intravenous ceftriaxone, ampicillin, and amoxicillin and oral amoxicillin and amoxicillin-clavulanic acid. Azithromycin or erythromycin may be added as well.
Drug: Standard of Care
Age- and weight-based dosing as appropriate per sites standard of care.
- Overview of Adverse Events By Treatment Arm [ Time Frame: Up to 28 days post-treatment ]Summary of subjects experiencing Treatment Emergent Adverse Events (TEAE) through Day 16 visit and Treatment Emergent Serious Adverse Events (TESAE) through Day 28 visit (28 days +/- 4 days after randomization)
- Summary of Early Clinical Response [ Time Frame: During Treatment Days 3 to 4 ]Early clinical response (ECR) was defined using the latest efficacy evaluation from Day 2 (if subject discharged prior to Day 2), Day3, or Day 4, and was defined as improvement in at least 1 presenting sign/symptom of CABP with no deterioration in any signs/symptoms of CABP and no requirement for an additional antibiotic.
- Summary of Clinical Improvement [ Time Frame: Last day of Treatment (+48 hours) ]Clinical improvement was assessed using the latest efficacy evaluation conducted on last day of treatment (+48 hours), and was defined identically to the early clinical response.
- Summary of Clinical Cure [ Time Frame: Short-term follow-up at 16 days (+/- 4 days) ]Clinical cure was assessed using the latest efficacy evaluation conducted on Day 16 (+/- 4 days) post-randomization, and was defined as resolution of all presenting signs/symptoms of CABP (excluding cough), no development of new signs/symptoms of CABP, and no requirement for an additional antibiotic.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02605122
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|Principal Investigator:||Michael Cohen-Wolkowiez, MD, PhD||Duke Clinical Research Institute|