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

Purpose

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.

Condition

  • Respiratory Syncytial Virus Infections

Eligibility

Eligible Ages
Between 3 Days and 2 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Control Group
  • Other: Control Group
    Saline will be given intravenous daily for 3 days once patients are consented and enrolled into the study.
Active Comparator
AZM 20mg/kg Treatment Group
  • 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.

Recruiting Locations

The University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Michele Kong, MD
205-638-9387
mkong@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Michele Kong, MD
205-638-9387
mkong@uabmc.edu

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 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.