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

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.

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