Prospective Pilot Clinical Trial of Azithromycin Treatment In RSV-Induced (Respiratory Syncytial Virus - Induced) Respiratory Failure In Children
Status: | Active, not recruiting |
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Conditions: | Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | Any - 16 |
Updated: | 4/6/2019 |
Start Date: | January 2016 |
End Date: | April 30, 2020 |
Prospective Pilot Clinical Trial of Azithromycin Treatment In RSV-Induced Respiratory Failure In Children
The proposed study will be a randomized, double masked, placebo-controlled pilot trial of
azithromycin treatment in children with RSV-induced respiratory failure.
azithromycin treatment in children with RSV-induced respiratory failure.
Study participants will be enrolled from the Pediatric Intensive Care Unit (PICU) at
Children's of Alabama. Samples collected will be analyzed in the PI's lab at the University
of Alabama at Birmingham. Drug pharmacokinetics will be performed at the Pharmaceutical
Sciences Research Institute of Samford University, Birmingham, AL.
Children's of Alabama. Samples collected will be analyzed in the PI's lab at the University
of Alabama at Birmingham. Drug pharmacokinetics will be performed at the Pharmaceutical
Sciences Research Institute of Samford University, Birmingham, AL.
Inclusion Criteria:
- Admission to the PICU with RSV infection
- Randomization and drug/placebo initiation within 48 hours of admission to Pediatric
Intensive Care Unit
Exclusion Criteria:
- Azithromycin use within 7 days of PICU admission
- Contraindication to azithromycin use including:
- Patients with electrocardiogram QT interval corrected for heart rate (Qtc) ≥ 450
ms
- Patients with significant hepatic impairment (direct bilirubin >1.5 mg/dL)
- Known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide
drug
- Cardiac arrhythmia
- History of pyloric stenosis
- Immunocompromised children (any cause)
- Current use of any medication known to cause QT prolongation
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