Recruiting

Phase 3

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

Sponsor:

University of Alabama at Birmingham

Code:

NCT05026749

Conditions

Respiratory Syncytial Virus Infections

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

AZM Group

Control Group

Study Details

Brief 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.

Conditions

Respiratory Syncytial Virus Infections

Study ID

NCT05026749

Start date

Feb 27, 2022

Status verified date

Feb, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

370 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Control Group

active comparator: AZM 20mg/kg Treatment Group

Interventions

AZM Group

AZM at 20 mg/kg will be given intravenous daily for 3 days once patients are consented and enrolled into the study.

Control Group

Saline will be given intravenous daily for 3 days once patients are consented and enrolled into the study.

Primary outcome measure

Length of Hospitalization [ Time Frame: At discharge (Approximately 2 weeks) ]

Central Contacts and Locations

Central contacts

Michele Kong, MD

205-638-9387 mkong@uabmc.edu

Locations

The University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Michele Kong, MD

205-638-9387 mkong@uabmc.edu

Principal Investigator:

Michele Kong, MD

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Matt Zinter, MD

Matt.Zinter@ucsf.edu

James Howard, MD

James.Howard@ucsf.edu

Yale School of Medicine

Recruiting

New Haven, Connecticut, United States, 06520-8064

Contacts

Vince Faustino, MD

vince.faustino@yale.edu

Children's National Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Michael Shoykhet, MD

mshoykhet@childrensnational.org

Ann & Robert H. Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Bria Coates, MD

b-coates@northwestern.edu

Riley Children's Health

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Michael J Hobson, MD

mjhobson@iu.edu

St. Louis Children's Hospital

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Ashley Turner, MD

(314) 454-6000 ashley.turner@wustl.edu

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Eleanor Gradidge, MD

egradidge@childrensnebraska.org

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Tracie Walker, MD

9198431577 tracie_walker@med.unc.edu

Rainbow Babies and Children's Hospital

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Steven Shein, MD

Steven.Shein@UHhospitals.org

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Katherine Bline, MD

katherine.bline@nationwidechildrens.org

Oklahoma Health Sciences

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Christine Allen, MD

Christine-allen@ouhsc.edu

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Garrett Keim, MD

215-590-3800 keimG@chop.edu

The University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75247

Contacts

Ananya Manchikalapati, MD

2144561600 ananya.manchikalapati@UTsouthwestern.edu

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Kevin Watt, MD

801-587-7404 kevin.watt@hsc.utah.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

RSV
AZM
ICU
Respiratory Support
Children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-02-09.