for people ages up to 2 years (full criteria)
at San Francisco, California and other locations
study started
completion around
Principal Investigator
by Matt Zinter, MDJames Howard, MD
Headshot of Matt Zinter
Matt Zinter



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.


The proposed study will be a randomized, double-blinded, placebo-controlled Phase III trial to examine the efficacy of AZM therapy relative to placebo in reducing RSV-related morbidity. Patients will be recruited during acute hospitalization and admission to the ICU at 7 pediatric hospitals. The target population selected is pediatric patients with severe RSV lung disease as defined by need for ICU management and intensive respiratory support.


Respiratory Syncytial Virus Infections, RSV, AZM, ICU, Respiratory Support, Children, Respiratory Insufficiency, AZM Group


You can join if…

Open to people ages up to 2 years

  • 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 CAN'T join 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).


  • UCSF accepting new patients
    San Francisco California 94143 United States
  • University of Nebraska Medical Center accepting new patients
    Omaha Nebraska 68198 United States

Lead Scientists at UCSF

  • Matt Zinter, MD
    I study the pathobiology of critical illness, including organ dysfunction and infection, in children with cancer, immunodeficiencies, and those who have undergone hematopoietic stem cell transplantation.
  • James Howard, MD
    Associate Professor, Pediatrics, School of Medicine


accepting new patients
Start Date
Completion Date
University of Alabama at Birmingham
Phase 3 RSV Research Study
Study Type
Expecting 370 study participants
Last Updated