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NCT05026749PHASE3Recruiting

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

University of Alabama at Birmingham

Start Date

2/27/2022

Completion Date

7/31/2028

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.

Detailed Description

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 10 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.

Eligibility Criteria

Age Range: No minimum to 2 years

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).

Interventions

DRUG

AZM Group

OTHER

Control Group

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Conditions

Respiratory Syncytial Virus Infections

Locations

The University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

University of California San Francisco

San Francisco, California 94143

United States

Yale School of Medicine

New Haven, Connecticut 06520-8064

United States

Children's National Hospital

Washington D.C., District of Columbia 20010

United States

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

Chicago, Illinois 60611

United States

Riley Children's Health

Indianapolis, Indiana 46202

United States

St. Louis Children's Hospital

St Louis, Missouri 63110

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

United States

Rainbow Babies and Children's Hospital

Cleveland, Ohio 44106

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

Oklahoma Health Sciences

Oklahoma City, Oklahoma 73104

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

The University of Texas Southwestern Medical Center

Dallas, Texas 75247

United States

University of Utah

Salt Lake City, Utah 84112

United States