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PEDIATRICS Vol. 100 No. 6 December 1997, pp. 937-942

Respiratory Syncytial Virus Immune Globulin Treatment of RSV Lower Respiratory Tract Infection in Previously Healthy Children

Received Sep 17, 1996; accepted May 13, 1997.

William J. Rodriguez*, William C. GruberDagger , Jessie R. Groothuis§, Eric A. F. Simoes§, Angela J. Rosasparallel , Martha Lepow, Andrew Kramer PhD#, Val Hemming**, and the RSV-IGIV Study Group

From the * Children's Hospital National Medical Center, Washington, DC; Dagger  Vanderbilt University Children's Hospital, Nashville, Tennessee; § the Children's Hospital, Denver, Colorado; parallel  West Virginia University Health Science Center, Morgantown, West Virginia;  Albany Medical College, Albany, New York; # MedImmune Inc, Gaithersburg, Maryland; and ** Uniformed Services University of Health Sciences, Bethesda, Maryland.

Objective.  To evaluate the efficacy of high titer respiratory syncytial virus (RSV) immune globulin (RSVIG) in the treatment of previously healthy children hospitalized with proven RSV lower tract infection (LRI).

Method.  Infants and young children <= 2 years of age with RSV LRI of <= 4 days duration, and respiratory scores >= 2.5 were enrolled.

Results.  One hundred and one previously healthy children hospitalized with RSV LRI received either 1500 mg/kg of RSVIG (RespiGam, MedImmune Inc, Gaithersburg, MD) or albumin placebo in a randomized, double-blind, placebo-controlled trial. Forty-six RSVIG and 52 recipients of placebo met all eligibility criteria. Demographic characteristics of the two groups were similar. More RSVIG recipients (46% vs 29%) had an SaO2 <= 85% at entry than did placebo recipients, but a higher proportion of placebo recipients required intensive care unit (ICU) care and mechanical ventilation at study entry. The mean RSV hospital stay was 5.52 ± 0.69 days (SE) for placebo and 4.58 ± 0.40 days for RSVIG. Additionally, there was an interaction between treatment group and entry respiratory score, which led to subgroup analysis. Children with modest respiratory illness did not receive any benefit from RSVIG therapy. RSVIG recipients with more severe illness (entry respiratory scores >= 3.0) had 1.6 fewer hospital days and 2.7 days less ICU stays.

Conclusion.  RSVIG infusions seemed safe and generally well tolerated. Although some beneficial effect trends were seen for those with more severe disease who were treated there was no evidence that treatment with RSVIG resulted in reduced hospitalization and reduced ICU stays in all children with RSV disease.

Key words: respiratory syncytial virus, bronchiolitis, lower respiratory tract infections, respiratory syncytial virus immune globulin, randomized, controlled trial.




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