Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
Recruiting
Phase 3Interventional Study
Respiratory Syncytial Virus Infections
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
3 Days – 2
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
370 (estimated)
Sponsor
University of Alabama at Birmingham · Other
Who this trial is looking for
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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.
Trial Locations
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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…
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).
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