RESPIRATORY SYNCYTIAL VIRUS IMMUNE GLOBULIN TREATMENT OF RSV LOWER RESPIRATORY-TRACT INFECTION IN PREVIOUSLY HEALTHY-CHILDREN

Objective. To evaluate the efficacy of high titer respiratory syncytia l virus (RSV) immune globulin (RSVIG) in the treatment of previously h ealthy children hospitalized with proven RSV lower tract infection (LR I). Method. Infants and young children less than or equal to 2 years o f age with RSV LRI of less than or equal to 4 days duration, and respi ratory scores greater than or equal to 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, Gaither sburg, MD) or albumin placebo in a randomized, double-blind, placebo-c ontrolled trial. Forty-six RSVIG and 52 recipients of placebo met all eligibility criteria. Demographic characteristics of the two groups we re similar. More RSVIG recipients (46% vs 29%) had an SaO(2) less than or equal to 85% at entry than did placebo recipients, but a higher pr oportion 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 RS VIG. Additionally, there was an interaction between treatment group an d entry respiratory score, which led to subgroup analysis. Children wi th modest respiratory illness did not receive any benefit from RSVIG t herapy. RSVIG recipients with more severe illness (entry respiratory s cores greater than or equal to 3.0) had 1.6 fewer hospital days and 2. 7 days less ICU stays. Conclusion. RSVIG infusions seemed safe and gen erally well tolerated. Although some beneficial effect trends were see n for those with more severe disease who were treated there was no evi dence that treatment with RSVIG resulted in reduced hospitalization an d reduced ICU stays in all children with RSV disease.