title: Motavizumab treatment of infants hospitalized with respiratory syncytial virus infection does not decrease viral load or severity of illness.
abstract: BACKGROUND
  This study was conducted to determine whether treatment with motavizumab, an anti-respiratory syncytial virus (RSV) monoclonal antibody, would decrease viral load and improve clinical outcomes in previously healthy term infants hospitalized with RSV lower respiratory tract infection.
  
  
  METHODS
  Infants hospitalized with lower respiratory tract infection and a positive RSV test performed locally were randomized to receive 1 intravenous dose of motavizumab (30 or 100 mg/kg) or placebo. Nasal wash samples were tested by real-time reverse transcriptase polymerase chain reaction at a central laboratory to determine viral load. Clinical data were collected during RSV hospitalization and at 12-month follow up.
  
  
  RESULTS
  Of 118 infants, 112 were confirmed RSV positive by real-time reverse transcriptase polymerase chain reaction. In each study group, median (range) RSV load (log10 copies/mL) decreased at a similar rate from baseline to study day 7 [motavizumab 30 mg/kg: 8.35 (2.5-9.5) to 5.03 (2.5-6.8); motavizumab 100 mg/kg: 8.22 (5.5-9.7) to 4.25 (2.5-8.0); placebo: 8.02 (6.7-9.8) to 5.17 (2.5-7.3)]. Median (range) duration of hospitalization was 3.05 (0.8-16.0), 2.99 (1.0-25.0) and 2.88 (0.8-11.7) days for the motavizumab 30 mg/kg, motavizumab 100 mg/kg and placebo groups, respectively. Six (8%) motavizumab and 0 placebo recipients were admitted to the intensive care unit and 4 required mechanical ventilation. The incidence of wheezing episodes during the 12-month follow up was comparable for all 3 groups.
  
  
  CONCLUSIONS
  Motavizumab had no appreciable effect on RSV viral load measured in the upper respiratory tract of children hospitalized for RSV lower respiratory tract infection. No differences were observed for duration of hospitalization, severity of illness measures or wheezing episodes during 12-month follow up in children treated with motavizumab or placebo.
authors.affiliation: From the *Nationwide Children's Hospital, Ohio State University College of Medicine, Columbus, OH; †Centro Para Vacunas En Desarrollo-Chile, Santiago, Chile; ‡Hospital del Niño, Ciudad de Panamá, Panamá; and §MedImmune, Gaithersburg, MD.
authors.forename: Octavio
authors.initials: O
authors.lastname: Ramilo
authors.forename: Rosanna
authors.initials: R
authors.lastname: Lagos
authors.forename: Xavier
authors.initials: X
authors.lastname: Sáez-Llorens
authors.forename: JoAnn
authors.initials: J
authors.lastname: Suzich
authors.forename: C Kathy
authors.initials: CK
authors.lastname: Wang
authors.forename: Kathryn M
authors.initials: KM
authors.lastname: Jensen
authors.forename: Brian S
authors.initials: BS
authors.lastname: Harris
authors.forename: Genevieve A
authors.initials: GA
authors.lastname: Losonsky
authors.forename: M Pamela
authors.initials: MP
authors.lastname: Griffin
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007902:Length of Stay; D008137:Longitudinal Studies; D008297:Male; D009296:Nasal Cavity / Q000821:virology; D010919:Placebos / Q000627:therapeutic use; D060888:Real-Time Polymerase Chain Reaction; D018357:Respiratory Syncytial Virus Infections / Q000188:drug therapy* / Q000473:pathology* / Q000821:virology; D018113:Respiratory Syncytial Virus, Human / Q000302:isolation & purification*; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012720:Severity of Illness Index; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000998:Antiviral Agents; D010919:Placebos; C506968:motavizumab