Phase 2 N=48 Randomized Quadruple-blind Treatment

Prospective Pilot Clinical Trial of Azithromycin Treatment In Respiratory Syncytial Virus (RSV)- Induced Respiratory Failure In Children

Respiratory Syncytial Virus

Bottom Line

View on ClinicalTrials.gov: NCT02707523 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2020

Primary outcome: Primary: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 — 0; 0; 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Azithromycin 10 mg (Drug); Azithromycin 20mg (Drug); Placebo (Drug)
Age: Pediatric
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Feb 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	0; 0; 0	—
PRIMARY Nasal Total Matrix Metalloproteinase (MMP)-9 Level	545; 267; 413	—
PRIMARY Pharmacokinetic-Plasma Half Life of AZM	0; 76; 102	—
PRIMARY Pharmacokinetic-Lung Half Life of AZM	0; 78; 385	—
SECONDARY Duration of Mechanical Ventilation in Days	4.8; 5.6; 2.6	—
SECONDARY Duration of BiPAP in Days	3.6; 0.4; 0.1	—
SECONDARY Duration of High Flow Nasal Cannula in Days	3.3; 2.4; 2.3	—
SECONDARY Duration of Oxygenation in Days	11; 9.6; 6.6	—
SECONDARY Duration of Hospitalization in Days	15.8; 11.8; 9.1	—
SECONDARY Duration of PICU Stay in Days	7.7; 8.1; 5.4	—

Summary

This randomized, double-blind, placebo-controlled phase 2 trial will be conducted at a single tertiary pediatric intensive care unit (PICU). The study will include children with RSV infection who were admitted to the pediatric intensive care unit and require respiratory support via positive pressure ventilation (invasive and noninvasive).

Eligibility Criteria

Inclusion Criteria

Admission to the PICU with RSV infection
Need for positive pressure ventilation (invasive and non-invasive)
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02707523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.