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

Recruiting now · Phase 3

Conditions studied: Respiratory Syncytial Virus Infections

In brief

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.

Key facts

Study ID

NCT05026749

Run by

University of Alabama at Birmingham

People needed

370

Starts

2022-02-27

Expected to finish

2028-07-31

Last updated by the study team

2026-02-09

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Admission to the pediatric ICU with a confirmed diagnosis of RSV infection. RSV infection is based on a positive nasal swab for RSV fluorescent antibody or via multiplex assay or culture;
• Requiring intensive respiratory support defined as either mechanical ventilation or NIV (BiPAP or CPAP) or HFNC (at >1 L/kg/min of flow
• Enrollment into the study within 48 hours of ICU admission and placement on intensive respiratory support;
• Onset of RSV-related symptoms must be less than 5 days
• Age: Neonates-2 years. For those less than 1 week of age, they must have been discharged home from the hospital after their birth.

You may not qualify if…

• AZM use within 7 days of ICU admission;
• Contraindication to AZM use including known hypersensitivity to AZM, erythromycin, any macrolide, or ketolide drug, patients with significant hepatic impairment (direct bilirubin >1.5 mg/dL or ALT ≥ 10 times the upper limits of normal);
• Patients with known cardiac disease, cardiac arrhythmia or with electrocardiogram QT interval corrected for heart rate (QTc) ≥ 450 milisecond (ms);
• Intensive respiratory support greater than 48 hours prior to ICU admission;
• Chronic ventilation or supplemental oxygen need at home;
• Immunosuppressive conditions such as those post heart or hematopoietic stem cell transplant or receiving chemotherapy and chronic steroids;
• History of pyloric stenosis;
• AZM is deemed necessary for clinical treatment (for instance, if patient has pertussis).

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• Yale School of Medicine — New Haven, Connecticut, United States (enrolling)
• Children's National Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• Riley Children's Health — Indianapolis, Indiana, United States (enrolling)
• St. Louis Children's Hospital — St Louis, Missouri, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
• Oklahoma Health Sciences — Oklahoma City, Oklahoma, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• The University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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