A randomized controlled trial of motavizumab versus palivizumab for the prophylaxis of serious respiratory syncytial virus disease in children with hemodynamically significant congenital heart disease.
Details
Serval ID
serval:BIB_FE97D37080B9
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
A randomized controlled trial of motavizumab versus palivizumab for the prophylaxis of serious respiratory syncytial virus disease in children with hemodynamically significant congenital heart disease.
Journal
Pediatric Research
Working group(s)
Motavizumab Cardiac Study Group
Contributor(s)
Salzer-Muhar U., Stein J., Tulzer G., Benatar A., Dessy H., De Wolf D., Gewillig M., Massin M., Sluysmans T., Suys B., Vandenberghe P., Bosheva M., Ghenev E., Krasteva M., Chakarova P., Dachev S., Galabov I., Georgieva A., Hristova E., Nedkova-Kolarova V., Rosmanova R., Tzonzarova MR., Kakadekar-Sankaran A., Sankaran-Kakadekar K., Langley J., Lebel M., Lee K-., McDonald J., Robinson J., Rosenberg H., Singh A., Biolek J., Brabec R., Cihar M., Jehlicka P., Kokstein Z., Liska K., Stranak Z., Windelborg Nielsen B., Denjoy I., Dumas de la Roque E., Escande B., Lupoglazoff J-., Marcon F., Morville P., Semama D., Simeoni U., Dalla Pozza R., Netz H., Dittrich S., Hofbeck M., Kececioglu D., Kramer HH., Motz R., Paul T., Peuster M., Wessel A., Adamovich K., Barkai L., Dicso F., Katona M., Miklós A., Miklós S., Nagy A., Szabo E., Szatmari A., Ashkenazi S., Barzilai A., Berger I., Mimouni F., Dagan R., Engelhard D., Kassis I., Schlesinger Y., Somekh E., Bitar F., Daou L., Sacy R., Dawid G., Gadzinowski J., Gornicka G., Kassur-Siemienska B., Kojro-Wojcieszonek A., Mackowska K., Korbal P., Sysa A., Szczepanski M., Wojtalik M., Baltserovich N., Bulatov V., Galustyan A., Gorbatikov K., Ivanov S., Lyubomudrov V., Solovieva O., Shadrin S., Sinelnikov Y., Casaldaliga J., Exposito J., Fernandez-Santamarina I., García de la Calzada D., García-Guereta L., Guia J., Guzman Cabañas J., Izquierdo M., Maroto E., Medrano C., Ortiz J., Perez A., Planell C., Rissech M., Rodriguez M., Santos J., Valls-i-Soler A., Zabala I., Jonzon A., Pesonen E., Sunnegardh J., Winberg P., Blackburn M., Bu'Lock F., Casey F., Daubeney P., Jani B., Marsh M., Tulloh R., Aouthmany M., Arrieta A., Goodman G., Atz A., Balaraman V., Bolivar J., Bratcher D., Breitbart R., Brenner J., Burchfield D., Cabalka A., Camitta M., Chintala K., Covitz W., Cripe L., Dennehy P., Domachowske J., Dooley K., Englund J., Fedderly R., Hoffman T., Fergie J., Finnigan J., Fox R., Freeman D., Friedman A., Gajarski R., Gremmels D., Gullquist S., Hall C., Henderson F., Hughes P., Lepow M., Ing F., Johns J., Johnson G., Rosen K., Kantak A., Kaufman D., Krilov L., Kuehl K., Kung G., Lamprecht C., Lieberman J., Meissner C., Miller S., Mott A., Nachman S., Nizet V., Null D., Paridon S., Parrish M., Polak M., Qureshi A., Rosenthal G., Reller M., Romero J., Rubin L., Saba Z., Sanchez P., Sang C., San Joaquin V., Schelonka R., Scholz T., Sharkey A., Silio M., Sondheimer H., Stevens J., Sullivan J., Tan C., Lieberman J., Welliver R., Wetzel G., White R., Wolkoff L., Yetman R., Yogev R.
ISSN
1530-0447 (Electronic)
ISSN-L
0031-3998
Publication state
Published
Issued date
2011
Peer-reviewed
Oui
Volume
70
Number
2
Pages
186-191
Language
english
Notes
Publication types: Clinical Trial, Phase II ; Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't Publication Status: ppublish
Abstract
Children with hemodynamically significant congenital heart disease (CHD) are at risk for serious respiratory syncytial virus (RSV) disease. This study was designed to assess the safety and tolerability of motavizumab versus palivizumab in children with CHD and was not powered for efficacy. Patients (n = 1236) aged ≤24 mo were randomized to receive five monthly doses (15 mg/kg) of motavizumab or palivizumab during the RSV season. Adverse events (AEs) and serious AEs (SAEs) were recorded through 30 d after the last dose. RSV hospitalizations and RSV outpatient medically attended lower respiratory tract infections (MALRI; season 2) were summarized. Approximately 93 and 50% of patients reported an AE or SAE, respectively. Skin events occurred in 19.3% of motavizumab recipients and 16.2% of palivizumab recipients. Rates of hospitalizations and RSV MALRI were similar between treatment groups [relative risk (RR): 0.75; 95% CI, 0.34-1.59 and RR: 0.49; 95% CI, 0.10-1.99, respectively; both p > 0.05]. Motavizumab and palivizumab had similar safety profiles in children with hemodynamically significantly CHD; with the exception of skin events which were increased in motavizumab recipients. Safety and efficacy were consistent with another study comparing motavizumab with palivizumab in premature infants without CHD.
Keywords
Antibodies, Monoclonal/adverse effects, Antibodies, Monoclonal/therapeutic use, Antibodies, Monoclonal, Humanized, Chemoprevention/methods, Heart Defects, Congenital/complications, Humans, Infant, Respiratory Syncytial Virus Infections/complications, Respiratory Syncytial Virus Infections/drug therapy, Respiratory Tract Infections/etiology, Reverse Transcriptase Polymerase Chain Reaction
Pubmed
Web of science
Open Access
Yes
Create date
22/02/2015 10:19
Last modification date
20/08/2019 17:29
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