title: Anti-inflammatory effect of prophylactic macrolides on children with chronic lung disease: a protocol for a double-blinded randomised controlled trial.
abstract: Recent studies suggest that the high mortality rate of respiratory viral infections is a result of an overactive neutrophilic inflammatory response. Macrolides have anti-inflammatory properties, including the ability to downregulate the inflammatory cascade, attenuate excessive cytokine production in viral infections, and may reduce virus-related exacerbations. In this study, we will test the hypothesis that prophylactic macrolides will reduce the severity of respiratory viral illness in children with chronic lung disease by preventing the full activation of the inflammatory cascade.
  
  
  
  A randomised double-blind placebo-controlled trial that will enrol 92 children to receive either azithromycin or placebo for a period of 3-6 months during two respiratory syncytial virus (RSV) seasons (2015-2016 and 2016-2017). We expect a reduction of at least 20% in the total number of days of unscheduled face-to-face encounters in the treatment group as compared with placebo group. Standard frequentist and Bayesian analyses will be performed using an intent-to-treat approach.
  
  
  
  We predict that the prophylactic use of azithromycin will reduce the morbidity associated with respiratory viral infections during the winter season in patients with chronic lung disease as evidenced by a reduction in the total number of days with unscheduled face-to-face provider encounters.
  
  
  
  This research study was approved by the Institutional Review Board of the University of Texas Health Science Center in Houston on 9 October 2014. On completion, the results will be published.
  
  
  
  NCT02544984.
authors.affiliation: Department of Pediatrics, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.
authors.forename: Ricardo A
authors.initials: RA
authors.lastname: Mosquera
authors.affiliation: Department of Pediatrics, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.
authors.forename: Ana M
authors.initials: AM
authors.lastname: Gomez-Rubio
authors.affiliation: Department of Pediatrics, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.
authors.forename: Tomika
authors.initials: T
authors.lastname: Harris
authors.affiliation: Department of Pediatrics, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.
authors.forename: Aravind
authors.initials: A
authors.lastname: Yadav
authors.affiliation: Department of Pediatrics, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.
authors.forename: Katrina
authors.initials: K
authors.lastname: McBeth
authors.affiliation: Department of Pediatrics, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.
authors.forename: Traci
authors.initials: T
authors.lastname: Gonzales
authors.affiliation: Department of Pediatrics, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.
authors.forename: Cindy
authors.initials: C
authors.lastname: Jon
authors.affiliation: Department of Pediatrics, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.
authors.forename: James
authors.initials: J
authors.lastname: Stark
authors.affiliation: Department of Pediatrics, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.
authors.forename: Elenir
authors.initials: E
authors.lastname: Avritscher
authors.affiliation: Department of Pediatrics, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.
authors.forename: Claudia
authors.initials: C
authors.lastname: Pedroza
authors.affiliation: Department of Pediatrics, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.
authors.forename: Keely
authors.initials: K
authors.lastname: Smith
authors.affiliation: Department of Pediatrics, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Colasurdo
authors.affiliation: Department of Pediatrics, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Wootton
authors.affiliation: Department of Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA.
authors.forename: Pedro
authors.initials: P
authors.lastname: Piedra
authors.affiliation: Department of Pediatrics, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.
authors.forename: Jon E
authors.initials: JE
authors.lastname: Tyson
authors.affiliation: Department of Pediatrics, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.
authors.forename: Cheryl
authors.initials: C
authors.lastname: Samuels
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D017963:Azithromycin / Q000627:therapeutic use*; D002675:Child, Preschool; D002908:Chronic Disease / Q000188:drug therapy* / Q000453:epidemiology / Q000517:prevention & control; D002985:Clinical Protocols; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D008171:Lung Diseases / Q000188:drug therapy* / Q000453:epidemiology / Q000517:prevention & control; D018942:Macrolides / Q000627:therapeutic use*; D008297:Male; D065129:Pre-Exposure Prophylaxis; D011788:Quality of Life; D012141:Respiratory Tract Infections / Q000188:drug therapy* / Q000453:epidemiology / Q000382:microbiology / Q000821:virology; D013781:Texas / Q000453:epidemiology; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D018942:Macrolides; D017963:Azithromycin
keywords: azithromycin; bronchopulmonary dysplasia; chronic lung disease; macrolides