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

RecruitingPhase 3

Who can join

3 Days – 2 Years · All sexes

Full eligibility criteria
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).

About the study

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.

What is being tested

Sponsor: University of Alabama at Birmingham · Participants: 370 · Started: Feb 27, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05026749

Locations in the U.S.

AlabamaThe University of Alabama at Birmingham, Birmingham
CaliforniaUniversity of California San Francisco, San Francisco
ConnecticutYale School of Medicine, New Haven
District of ColumbiaChildren's National Hospital, Washington D.C.
IllinoisAnn & Robert H. Lurie Children's Hospital of Chicago, Chicago
IndianaRiley Children's Health, Indianapolis
MissouriSt. Louis Children's Hospital, St Louis
NebraskaUniversity of Nebraska Medical Center, Omaha
North CarolinaUniversity of North Carolina at Chapel Hill, Chapel Hill
OhioRainbow Babies and Children's Hospital, Cleveland
Nationwide Children's Hospital, Columbus
OklahomaOklahoma Health Sciences, Oklahoma City
PennsylvaniaChildren's Hospital of Philadelphia, Philadelphia
TexasThe University of Texas Southwestern Medical Center, Dallas
UtahUniversity of Utah, Salt Lake City

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.