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

This is an interventional treatment trial for Community-acquired Bacterial Pneumonia focused on measuring pneumonia, macrolide, pediatric Read More

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