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PMID: 9815203 Published · ppublish English Clinical Trial Clinical Trial, Phase II Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Reduction of respiratory syncytial virus (RSV) in tracheal aspirates in intubated infants by use of humanized monoclonal antibody to RSV F protein.

The Journal of infectious diseases ·Vol. 178 ·No. 6 ·1998-12-00 ·Pages 1555-61

Malley R, DeVincenzo J, Ramilo O, Dennehy PH, Meissner HC, Gruber WC, Sanchez PJ, Jafri H, Balsley J, Carlin D, Buckingham S, Vernacchio L, Ambrosino DM

Abstract

Thirty-five children <2 years of age mechanically ventilated for respiratory syncytial virus (RSV) infection were randomized to receive an intravenous infusion of 15 mg/kg MEDI-493 or placebo. RSV concentration was measured in tracheal secretions by plaque assay before and at 24-h intervals after treatment. The reduction in tracheal RSV concentration from day 0 to day 1 (-1.7+/-0.28 vs. -0. 6+/-0.21 log10 pfu/mL; P=.004) and from day 0 to day 2 (-2.5+/-0.26 vs. -1.0+/-0.41 log10 pfu/mL; P=.012) was significantly greater in the MEDI-493 group than in the placebo group. RSV concentration in nasal aspirates did not differ significantly between the groups. No significant differences were observed in the tracheal aspirate white blood cell count, or myeloperoxidase or eosinophilic cationic protein concentration, or in measures of disease severity between the groups. Thus, treatment with 15 mg/kg MEDI-493 intravenously was well-tolerated and significantly reduced RSV concentration in tracheal aspirates of children with respiratory failure due to RSV.

MeSH Terms
Antibodies, Monoclonal/administration & dosage,therapeutic use Antibodies, Monoclonal, Humanized Female HN Protein Humans Infant Infusions, Intravenous Intubation Male Palivizumab Respiration, Artificial Respiratory Syncytial Virus Infections/therapy Respiratory Syncytial Viruses/isolation & purification,physiology Trachea/virology Viral Envelope Proteins Viral Fusion Proteins/immunology Viral Proteins/immunology
Chemicals
Antibodies, Monoclonal Antibodies, Monoclonal, Humanized HN Protein Viral Envelope Proteins Viral Fusion Proteins Viral Proteins attachment protein G Palivizumab
Authors & Affiliations
13 authors, click to expand affiliations / ORCID
Malley R
Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, MA 02115, USA. malley@al.tch.harvard.edu
DeVincenzo J
Ramilo O
Dennehy P H
Meissner H C
Gruber W C
Sanchez P J
Jafri H
Balsley J
Carlin D
Buckingham S
Vernacchio L
Ambrosino D M
Article Info
Journal
The Journal of infectious diseases
Abbr.
J Infect Dis
ISSN
0022-1899
Published
1998-12-00
Pages
1555-61
Language
English
Region
United States
NLM ID
0413675
Subset
IM
Corrections
CommentIn
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