NCT05026749 Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
| NCT ID | NCT05026749 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Alabama at Birmingham |
| Condition | Respiratory Syncytial Virus Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 370 participants |
| Start Date | 2022-02-27 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 370 participants in total. It began in 2022-02-27 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Michele Kong, MD
PRINCIPAL INVESTIGATOR
The University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT05026749 clinical trial?
This trial is open to participants of all sexes, aged 3 Days or older, up to 2 Years, studying Respiratory Syncytial Virus Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05026749 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 370 participants.
Is NCT05026749 currently recruiting?
Yes, NCT05026749 is actively recruiting participants. Contact the research team at mkong@uabmc.edu for enrollment information.
Where is the NCT05026749 trial being conducted?
This trial is being conducted at Birmingham, United States, San Francisco, United States, New Haven, United States, Washington D.C., United States and 11 additional locations.
Who is sponsoring the NCT05026749 clinical trial?
NCT05026749 is sponsored by University of Alabama at Birmingham. The principal investigator is Michele Kong, MD at The University of Alabama at Birmingham. The trial plans to enroll 370 participants.