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

Stopped early · Phase 2/Phase 3

Conditions studied: Community-acquired Bacterial Pneumonia

In brief

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).

Key facts

Study ID

NCT02605122

Run by

Melinta Therapeutics, Inc.

People needed

97

Starts

2016-04-01

Expected to finish

2018-03-21

Last updated by the study team

2019-01-03

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Ventilator-associated or hospital-acquired pneumonia
• >48 hours of systemic antibacterial therapy
• confirmed or suspected bacterial meningitis
• breast-feeding females
• positive pregnancy test

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Tampa, Florida, United States
• Study site — Louisville, Kentucky, United States
• Study site — Omaha, Nebraska, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Durham, North Carolina, United States
• Study site — Greenville, North Carolina, United States
• Study site — Toledo, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Hershey, Pennsylvania, United States
• Study site — Memphis, Tennessee, United States
• Study site — Amarillo, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Splendora, Texas, United States
• Study site — Charlottesville, Virginia, United States
• Study site — Richmond, Virginia, United States
• Study site — Roanoke, Virginia, United States
• Study site — Pleven, Bulgaria
• Study site — Plovdiv, Bulgaria
• Study site — Rousse, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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