RecruitingPhase 3NCT05026749
Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
Sponsor
University of Alabama at Birmingham
Enrollment
370 participants
Start Date
Feb 27, 2022
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 3 DaysMax Age: 2 Years
Inclusion Criteria5
- 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 Criteria8
- 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).
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Interventions
DRUGAZM Group
AZM at 20 mg/kg will be given intravenous daily for 3 days once patients are consented and enrolled into the study.
OTHERControl Group
Saline will be given intravenous daily for 3 days once patients are consented and enrolled into the study.
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT05026749
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