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

NCT05026749 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2026-02-09

No results posted yet for this study

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.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

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.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Michele Kong, MD · The University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Days
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-27
Primary Completion
2027-07-01
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05026749 on ClinicalTrials.gov