Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Aug 24, 2021

Keywords

ClinConnect Summary

The clinical trial titled "Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children" is studying whether the antibiotic azithromycin can help children who are experiencing severe breathing problems caused by a virus called Respiratory Syncytial Virus (RSV). The trial aims to find out if giving this medication in the pediatric intensive care unit (ICU) can improve recovery for kids with RSV who need intensive support, like mechanical ventilation or special breathing treatments.

To participate in this trial, children aged 3 days to 2 years must be admitted to the pediatric ICU with a confirmed RSV infection and need intensive breathing support within 48 hours of admission. However, certain children cannot join, such as those who have recently used azithromycin or have specific health conditions that would make the use of this medication unsafe. If eligible, participants will receive either azithromycin or a placebo (a substance with no active medicine) while being closely monitored by healthcare professionals. This trial is currently recruiting participants, and it’s important for families to discuss with their doctors if they think their child might qualify.

Gender

ALL

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).