Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Melinta Therapeutics, Inc.
With
Biomedical Advanced Research and Development Authority
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.
Age
0–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be if
Ventilator-associated or hospital-acquired pneumonia
