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

• Status: Terminated
• Trial end date: 2018-03-21
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cempra Inc; Melinta Therapeutics, Inc.
• Collaborator: Biomedical Advanced Research and Development Authority
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Azithromycin; Ceftriaxone; Clavulanic Acid; Clavulanic Acids; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin lactobionate; Erythromycin stearate; Solithromycin

Criteria

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