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

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