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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02605122
• Other study ID #: CE01-203
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: April 2016
• Est. completion date: March 21, 2018

Study information

• Verified date: November 2018
• Source: Cempra Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 97
• Est. completion date: March 21, 2018
• Est. primary completion date: March 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 17 Years

Eligibility

Inclusion Criteria:

• History of and/or documented fever (rectal, ear, or oral temperature =38°C or axillary temperature =37.5°C) or hypothermia (rectal, ear, or oral temperature <35°C or axillary temperature <34.5°C)

• Chest radiograph infiltrates consistent with bacterial pneumonia (or pneumonia caused by atypical bacterial agents); if a subject is outpatient and starting on oral therapy, a radiograph is not required.

• Presence of at least 2 of the following signs or symptoms:

• Cough

• Difficulty breathing

• Production of purulent sputum

• Chest pain

• Grunting

• Hypotension

• Tachycardia, defined as follows:

2 months to <24 months: =160 beats/min 24 months to <10 years: =140 beats/min

• 10 years: =100 beats/min

• Tachypnea, defined as follows:

2 months to <12 months: =50 breaths/min 12 months to <5 years: =40 breaths/min

• 5 years: =20 breaths/min

• Physical exam consistent with pulmonary consolidation

• Presence of at least 1 of the following:

• Leukocytosis (=12,000 white blood cells [WBC]/mm3)

• Leukopenia (<5000 WBC/mm3)

• =10% immature neutrophils (bands) regardless of total peripheral WBC

• Elevated inflammatory markers (C-reactive protein or procalcitonin)

• Oxygen saturation <97% on room air

• Organism consistent with a typical respiratory pathogen identified

Exclusion Criteria:

• Ventilator-associated or hospital-acquired pneumonia

• >48 hours of systemic antibacterial therapy

• confirmed or suspected bacterial meningitis

• breast-feeding females

• positive pregnancy test

Related Conditions & MeSH terms

• Community-acquired Bacterial Pneumonia
• Pneumonia
• Pneumonia, Bacterial

Intervention

Drug:
• Solithromycin

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cempra Inc	Biomedical Advanced Research and Development Authority

Countries where clinical trial is conducted

United States,  Bulgaria,  Hungary,  Philippines,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overview of Adverse Events By Treatment Arm	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)	Up to 28 days post-treatment
Secondary	Summary of Early Clinical Response	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.	During Treatment Days 3 to 4
Secondary	Summary of Clinical Improvement	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.	Last day of Treatment (+48 hours)
Secondary	Summary of Clinical Cure	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.	Short-term follow-up at 16 days (+/- 4 days)