Phase III Study of Intravenous Azithromycin for Severe RSV Respiratory Failure in Children Up to 2 Years in Pediatric ICU

What this Trial Is About

Researchers are investigating the use of Azithromycin AZM to treat children with severe Respiratory Syncytial Virus RSV-induced respiratory failure. This randomized, double-blinded, placebo-controlled Phase III trial aims to see if AZM can reduce illness severity by affecting a specific biological pathway called matrix metalloproteinase MMP-9. The study focuses on pediatric patients who need intensive care and respiratory support due to RSV lung disease. Participants will be randomly assigned to receive either AZM or a placebo. Those in the AZM group will get 20 mgkg of the drug intravenously once daily for three days. The control group will receive saline intravenously on the same schedule. Patients will be recruited during their acute hospitalization and admission to the intensive care unit at selected pediatric hospitals. Throughout the study, researchers will monitor participants closely, including measuring how long they stay in the hospital and intensive care unit, as well as how long they require oxygen support. These assessments will occur around one to two weeks after treatment starts. The study will help determine if AZM can improve recovery times in children facing severe RSV infections, with safety and treatment effects carefully observed during the trial period.

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