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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

DRUG

AZM Group

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

OTHER

Control Group

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

Locations (15)

The University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California San Francisco
San Francisco, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
Children's National Hospital
Washington D.C., District of Columbia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Riley Children's Health
Indianapolis, Indiana, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oklahoma Health Sciences
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Utah
Salt Lake City, Utah, United States