Azithromycin treatment for children with severe RSV respiratory failure

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

This study is testing if the antibiotic Azithromycin can help children with severe respiratory failure caused by RSV feel better and recover faster.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 370 (estimated)
• Ages: 3 Days to 2 Years
• Sex: All
• Sponsor: University of Alabama at Birmingham (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 15 sites (Birmingham, Alabama and 14 other locations)
• Trial ID: NCT05026749 on ClinicalTrials.gov

What this trial studies

This Phase III trial investigates the effectiveness of Azithromycin (AZM) in treating pediatric patients suffering from severe respiratory failure due to Respiratory Syncytial Virus (RSV). The study is designed as a randomized, double-blinded, placebo-controlled trial, comparing AZM therapy to a placebo in reducing morbidity associated with RSV. Participants will be recruited from pediatric ICUs across 10 hospitals, focusing on those requiring intensive respiratory support. The trial aims to enroll patients within 48 hours of ICU admission and onset of RSV symptoms within the last 5 days.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients aged neonates to 2 years who are admitted to the ICU with confirmed RSV infection and require intensive respiratory support.

Not a fit: Patients who have received Azithromycin within the past 7 days or have contraindications to its use will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the severity of respiratory failure in children with RSV, potentially improving recovery outcomes.

How similar studies have performed: While the use of Azithromycin for RSV is being explored, this specific approach in a pediatric ICU setting is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion criteria:

* 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.

Exclusion criteria:

* 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 this trial is running

Birmingham, Alabama and 14 other locations

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

Study contacts

• Principal investigator: Michele Kong, MD — The University of Alabama at Birmingham
• Study coordinator: Michele Kong, MD

Conditions Respiratory Syncytial Virus Infections; RSV; AZM; ICU; Respiratory Support; Children