Azithromycin does not improve disease course in hospitalized infants with respiratory syncytial virus (RSV) lower respiratory tract disease: A randomized equivalence trial

• Published in: Pediatric pulmonology 2008-02, Vol.43 (2), p.142-149
• Main Authors: Kneyber, Martin C.J., van Woensel, Job B.M., Uijtendaal, Esther, Uiterwaal, Cuno S.P.M., Kimpen, Jan L.L.
• Format: Article
• Language: English
• Subjects: Anti-Bacterial Agents - therapeutic use; Antibacterial agents; antibiotics; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiviral Agents - administration & dosage; Antiviral Agents - therapeutic use; Azithromycin - administration & dosage; Azithromycin - therapeutic use; Biological and medical sciences; Chi-Square Distribution; children; Double-Blind Method; Enteral Nutrition; Female; General aspects; Human viral diseases; Humans; Infant; Infant, Newborn; Infectious diseases; Intensive Care Units, Pediatric; Intubation, Gastrointestinal; Length of Stay; Male; Medical sciences; Oxygen - administration & dosage; Patient Selection; Pharmacology. Drug treatments; Pneumology; randomized controlled trial; Referral and Consultation; Research Design; Respiratory Syncytial Virus Infections - drug therapy; RSV; Severity of Illness Index; Statistics, Nonparametric; Therapeutic Equivalency; Viral diseases; Viral diseases of the respiratory system and ent viral diseases
• ISSN: 8755-6863; 1099-0496
• DOI: 10.1002/ppul.20748

Background Nearly half of all hospitalized infants with respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) are treated with (parenteral) antibiotics. The present study was designed to test our hypothesis that the use of antibiotics would not lead to a reduced duration of hospitalization in mild to moderate RSV LRTD. Methods Seventy‐one patients ≤24 months of age with a virologically confirmed clinical diagnosis of RSV LRTD were randomized to azithromycin 10 mg/kg/day (n = 32) or placebo (n = 39) in a multicenter, randomized, double‐blind, placebo‐controlled equivalence trial during three RSV seasons (2002–2004 through 2005–2006). Primary endpoint was duration of hospitalization, secondary endpoints included duration of oxygen supplementation and nasogastric tube feeding, course of RSV symptom score, number of PICU referrals and number of patients who received additional antibiotic treatment. Data were analyzed according to the intention‐to‐treat principle using the Mann–Whitney U‐test or χ2 test considering P