Expired Study
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Washington, District of Columbia 20010


Purpose:

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).


Study summary:

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.


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


NCT ID:

NCT02605122


Primary Contact:

Principal Investigator
Michael Cohen-Wolkowiez, MD, PhD
Duke Clinical Research Institute


Backup Contact:

N/A


Location Contact:

Washington, District of Columbia 20010
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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