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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

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 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.