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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).

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

A healthcare provider designated as a sub-investigator blinded to treatment allocation at the site documented clinical response at specified time points during the study.

Study Site will not submit its results for independent publication until after a coordinated, multicenter Study publication has been submitted or one (1) year after the conclusion of the Study, whichever occurs first. Study Site and/or Investigator shall submit any proposed publication or presentation resulting from Study Site's performance of the Protocol to the Prime Recipient for review and comment at least forty-five (45) days prior to the date of submission.