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โ† Trials
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Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children

RecruitingPhase 3Ages 3 Days - 2 YearsAllUniversity of Alabama at Birmingham
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 10 times the upper limits of normal); * Patients with known cardiac disease, cardiac arrhythmia or with electrocardiogram QT interval corrected for heart rate (QTc) โ‰ฅ 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).
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What it tests

  • AZM Group
  • Control Group
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Where

15 sites
The University of Alabama at Birmingham
Birmingham, United States
University of California San Francisco
San Francisco, United States
Yale School of Medicine
New Haven, United States
Children's National Hospital
Washington D.C., United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, United States
Riley Children's Health
Indianapolis, United States
St. Louis Children's Hospital
St Louis, United States
University of Nebraska Medical Center
Omaha, United States

โ€ฆand 7 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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