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

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05026749
• Other study ID #: IRB-300007862
• Status: Recruiting
• Phase: Phase 3
• Start date: February 27, 2022
• Est. completion date: July 31, 2026

Study information

• Verified date: November 2023
• Source: University of Alabama at Birmingham
• Contact: Michele Kong, MD
• Phone: 205-638-9387
• Email: mkong[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 7 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 370
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Days to 2 Years

Eligibility

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).

Related Conditions & MeSH terms

• Respiratory Insufficiency
• Respiratory Syncytial Virus Infections

Intervention

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

Country	Name	City	State
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Yale School of Medicine	New Haven	Connecticut
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	University of California San Francisco	San Francisco	California
United States	Children's National Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Hospitalization	Duration of hospitalization in days for enrolled subjects	At discharge (Approximately 2 weeks)
Secondary	Duration of oxygenation	Duration of oxygenation in days for enrolled subject	At discharge (Approximately 1 week)
Secondary	Length of ICU stay	Duration of ICU stay in days for enrolled subjects	At ICU discharge (Approximately 1 week)