NCT05026749

Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 370 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 3 Days – 2 Years
• Healthy volunteers: Not accepted

Summary

The overarching hypothesis of the ARRC trial is that administration of Azithromycin (AZM) during acute, Respiratory Syncytial Virus (RSV)-induced respiratory failure will be beneficial, mediated through the matrix metalloproteinase (MMP)-9 pathway.

Detailed description

The proposed study will be a randomized, double-blinded, placebo-controlled Phase III trial to examine the efficacy of AZM therapy relative to placebo in reducing RSV-related morbidity. Patients will be recruited during acute hospitalization and admission to the ICU at 10 pediatric hospitals. The target population selected is pediatric patients with severe RSV lung disease as defined by need for ICU management and intensive respiratory support.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
DRUG	AZM Group	AZM at 20 mg/kg will be given intravenous daily for 3 days once patients are consented and enrolled into the study.
OTHER	Control Group	Saline will be given intravenous daily for 3 days once patients are consented and enrolled into the study.

Timeline

• Start date: 2022-02-27
• Primary completion: 2027-07-01
• Completion: 2028-07-31
• First posted: 2021-08-30
• Last updated: 2026-02-09

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study