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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Control Group |
|
|
|
Active Comparator AZM 20mg/kg Treatment Group |
|
Recruiting Locations
Children's National and nearby locations
Children's National Hospital
Washington, District of Columbia 20010
Washington, District of Columbia 20010
More Details
- NCT ID
- NCT05026749
- Status
- Recruiting
- Sponsor
- University of Alabama at Birmingham
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.