Summary

Eligibility
for people ages up to 2 years (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Details

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 5 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.

Keywords

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

Eligibility

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, with a minimum of 5L/min flow for children <5 kg);
  • Enrollment into the study within 48 hours of ICU admission and placement on intensive respiratory support;
  • 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);
  • 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).

Locations

  • University of California San Francisco
    San Francisco California 94143 United States
  • Ann & Robert H. Lurie Children's Hospital of Chicago
    Chicago Illinois 60611 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of Alabama at Birmingham
ID
NCT05026749
Phase
Phase 3
Study Type
Interventional
Last Updated