RESPIRATORY SYNCYTIAL VIRUS (RSV) IMMUNE GLOBULIN INTRAVENOUS THERAPYFOR RSV LOWER RESPIRATORY-TRACT INFECTION IN INFANTS AND YOUNG-CHILDREN AT HIGH-RISK FOR SEVERE RSV INFECTIONS

Objectives. To evaluate the efficacy of high-titer intravenous respira tory syncytial virus immune globulin (RSVIG) in the treatment of child ren at high risk for severe RSV infection who were hospitalized with p roven RSV. Methods. Infants and young children younger than 2 years wi th bronchopulmonary dysplasia, chronic lung disease, congenital heart disease, or prematurity (<32 weeks' gestational age), hospitalized wit h a history of lower respiratory tract infection (LRI) of less than 4 days, were enrolled in this study. Patients were randomized in a blind ed fashion to receive either 1500 mg/kg RSVIG or placebo in equal volu mes. They were evaluated daily for safety and respiratory scores and f or RSV nasal shedding. Results. One hundred seven high-risk children w ere randomized-54 in the RSVIG group and 53 in the placebo group. Of t hese children, 51 in each group were considered evaluable. Children wi th pulmonary disease, congenital heart disease, or prematurity were eq ually distributed between the two treatment groups. However, two impor tant differences were found in baseline variables between the two grou ps: there were more patients in the placebo group who had histories of previous LRI and there was a trend toward more severe disease at stud y entry in the RSVIG group. This was manifested by a higher entry resp iratory score in the RSVIG group than in the placebo group (3.4 +/- 0. 2 vs 3.1 +/- .01). A higher proportion of children in the RSVIG group (47%) than in the placebo group (28%) required intensive care at entry and mechanical ventilation at study entry (31% RSVIG-treated vs 18% p lacebo-treated patients). No significant difference was found between groups in the mean unadjusted duration of hospitalization (RSVIG group , 9.10 +/- 1.18 days; control group, 8.17 +/- 1.08 days), When the mea n was adjusted for entry respiratory score, likewise, no difference wa s observed between each group (8.41 +/- 0.97 vs 8.89 +/- .99 days), Th e lack of efficacy observed in the study primary endpoint was observed in all diagnostic groups. No differences between the RSVIG and placeb o groups were observed in the following secondary endpoints: duration of intensive care unit stay, duration of intensive care unit stay for RSV, mechanical ventilation, or supplemental oxygen. No significant di fferences in adverse events were reported in the RSVIG group (16 child ren) when compared with the control group (10 children). Conclusion. R SVIG treatment was safe but not efficacious in the treatment of childr en with bronchopulmonary dysplasia, congenital heart disease, or prema ture gestation who were hospitalized with RSV LRI.