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

Phase 3

Recruiting

• Conditions: Respiratory Syncytial Virus Infections
• Interventions: Other: Control Group; Drug: AZM Group

• Registration Number: NCT05026749
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Study Timeline

• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-30
• Study Start: 2022-02-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-02-01
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control Group	-
AZM 20mg/kg Treatment Group	AZM Group	-

Primary Outcome Measures

Name	Time	Method
Length of Hospitalization	At discharge (Approximately 2 weeks)	Duration of hospitalization in days for enrolled subjects

Secondary Outcome Measures

Name	Time	Method
Duration of oxygenation	At discharge (Approximately 1 week)	Duration of oxygenation in days for enrolled subject
Length of ICU stay	At ICU discharge (Approximately 1 week)	Duration of ICU stay in days for enrolled subjects

Trial Locations

Locations (10)

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Riley Children's Health; 🇺🇸 Indianapolis, Indiana, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Children's National Hospital; 🇺🇸 Washington, District of Columbia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Rainbow Babies and Children's Hospital; 🇺🇸 Cleveland, Ohio, United States

Oklahoma Health Sciences; 🇺🇸 Oklahoma City, Oklahoma, United States