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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Respiratory Syncytial Virus Infections
Intervention / Treatment

-

Contacts and Locations

Birmingham

The University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

San Francisco

University of California San Francisco, San Francisco, California, United States, 94143

New Haven

Yale School of Medicine, New Haven, Connecticut, United States, 06520-8064

Washington

Children's National Hospital, Washington, District of Columbia, United States, 20010

Chicago

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, 60611

Indianapolis

Riley Children's Health, Indianapolis, Indiana, United States, 46202

Omaha

University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198

Cleveland

Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States, 44106

Columbus

Nationwide Children's Hospital, Columbus, Ohio, United States, 43205

Oklahoma City

Oklahoma Health Sciences, Oklahoma City, Oklahoma, United States, 73104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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).

Ages Eligible for Study

3 Days to 2 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Alabama at Birmingham,

Michele Kong, MD, PRINCIPAL_INVESTIGATOR, The University of Alabama at Birmingham

Study Record Dates

2026-07-31