title: Azithromycin therapy in hospitalized infants with acute bronchiolitis is not associated with better clinical outcomes: a randomized, double-blinded, and placebo-controlled clinical trial.
abstract: OBJECTIVE
  To test the hypothesis that azithromycin reduces the length of hospitalization and oxygen requirement in infants with acute viral bronchiolitis (AB).
  
  
  METHODS
  We performed a randomized, double-blinded, placebo-controlled trial in southern Brazil, from 2009 to 2011. Infants (<12 months of age) hospitalized with AB were recruited in 2 hospitals. Patients were randomized to receive either azithromycin or placebo, administered orally, for 7 days. At enrollment, clinical data were recorded and nasopharyngeal samples were collected for viral identification through immunofluorescence. Main outcomes were duration of oxygen requirement and length of hospitalization.
  
  
  RESULTS
  One hundred eighty-four patients were included in the study (azithromycin 88 subjects, placebo 96 subjects). Baseline clinical characteristics and viral identification were not different between the groups studied. A virus was detected in 112 (63%) patients, and of those, 92% were positive for respiratory syncytial virus. The use of azithromycin did not reduce the median number of days of either hospitalization (P = .28) or oxygen requirement (P = .47).
  
  
  CONCLUSIONS
  Azithromycin did not improve major clinical outcomes in a large sample of hospitalized infants with AB, even when restricting the findings to those with positive respiratory syncytial virus samples. Azithromycin therapy should not be given for AB because it provides no benefit and overuse increases overall antibiotic resistance.
authors: Department of Pediatrics, Hospital São Lucas and Institute of Biomedical Research, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil. leonardo.pinto@pucrs.br
authors: Leonardo A
authors: LA
authors: Pinto
authors: Paulo M
authors: PM
authors: Pitrez
authors: Fernanda
authors: F
authors: Luisi
authors: Patricia Piccoli
authors: PP
authors: de Mello
authors: Moisés
authors: M
authors: Gerhardt
authors: Roberta
authors: R
authors: Ferlini
authors: Daniel Cardoso
authors: DC
authors: Barbosa
authors: Ivana
authors: I
authors: Daros
authors: Marcus H
authors: MH
authors: Jones
authors: Renato T
authors: RT
authors: Stein
authors: Paulo J
authors: PJ
authors: Marostica
mesh_terms: D000208:Acute Disease; D000284:Administration, Oral; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D017963:Azithromycin / Q000627:therapeutic use*; D001990:Bronchiolitis, Viral / Q000175:diagnosis / Q000188:drug therapy* / Q000628:therapy; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006760:Hospitalization; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007251:Influenza, Human / Q000175:diagnosis / Q000188:drug therapy* / Q000628:therapy; D053208:Kaplan-Meier Estimate; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D010102:Oxygen Inhalation Therapy; D018184:Paramyxoviridae Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000628:therapy; D018357:Respiratory Syncytial Virus Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000628:therapy; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D017963:Azithromycin