Azithromycin treatment for children with severe RSV respiratory failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Michele Kong, MD — The University of Alabama at Birmingham
• Study coordinator: Michele Kong, MD
• Email: mkong@uabmc.edu
• Phone: 205-638-9387

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.