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

NCT ID: NCT05026749

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 370 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-27
• Study Completion Date: 2026-07-31

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.

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.

Conditions

Respiratory Syncytial Virus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control Group

Group Type: PLACEBO_COMPARATOR

Control Group

Intervention Type: OTHER

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

AZM 20mg/kg Treatment Group

Group Type: ACTIVE_COMPARATOR

AZM Group

Intervention Type: DRUG

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

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.

Intervention Type: DRUG

Control Group

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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Michele Kong, MD

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Kong, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Alabama at Birmingham

Locations

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

University of California San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Yale School of Medicine

New Haven, Connecticut, United States

Site Status: RECRUITING

Children's National Hospital

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

Site Status: RECRUITING

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

Chicago, Illinois, United States

Site Status: RECRUITING

Riley Children's Health

Indianapolis, Indiana, United States

Site Status: RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status: RECRUITING

Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Site Status: RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status: RECRUITING

Oklahoma Health Sciences

Oklahoma City, Oklahoma, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michele Kong, MD

Role: CONTACT

mkong@uabmc.edu

205-638-9387

Facility Contacts

Michele Kong, MD

Role: primary

mkong@uabmc.edu

205-638-9387

Matt Zinter, MD

Role: primary

Matt.Zinter@ucsf.edu

James Howard, MD

Role: backup

James.Howard@ucsf.edu

Vince Faustino, MD

Role: primary

vince.faustino@yale.edu

Michael Shoykhet, MD

Role: primary

mshoykhet@childrensnational.org

Bria Coates, MD

Role: primary

b-coates@northwestern.edu

Michael J Hobson, MD

Role: primary

mjhobson@iu.edu

Eleanor Gradidge, MD

Role: primary

egradidge@childrensnebraska.org

Steven Shein, MD

Role: primary

Steven.Shein@UHhospitals.org

Katherine Bline, MD

Role: primary

katherine.bline@nationwidechildrens.org

Christine Allen, MD

Role: primary

Christine-allen@ouhsc.edu

Other Identifiers

IRB-300007862

Identifier Type: -

Identifier Source: org_study_id