Impact of registration on clinical trials on infection risk in pediatric acute myeloid leukemia

Authors

David Dix, BC​ Children​'​​s Hospital
Richard Aplenc, The Children's Hospital of Philadelphia
Lynette Bowes, New Janeway Children’s Health and Rehabilitation Centre
Sonia Cellot, CHU Sainte-Justine - Le Centre Hospitalier Universitaire Mère-Enfant
Marie Chantal Ethier, Hospital for Sick Children University of Toronto
Jim Feusner, UCSF Benioff Children's Hospital Oakland
Biljana Gillmeister, Hospital for Sick Children University of Toronto
Donna L. Johnston, Children's Hospital of Eastern Ontario, Ottawa
Victor Lewis, Alberta Children's Hospital
Bruno Michon, CHU de Québec - Université Laval
David Mitchell, Centre Universitaire de Santé McGill, Hôpital de Montreal Pour Enfants
Carol Portwine, Hamilton Health Sciences
Victoria Price, IWK Health Centre
Mariana Silva, Hematology/Oncology
Kent Stobart, University of Alberta Hospital
Rochelle Yanofsky, CancerCare Manitoba
Shayna Zelcer, London Health SciencesFollow
Joseph Beyene, McMaster University
Lillian Sung, Hospital for Sick Children University of Toronto

Document Type

Article

Publication Date

4-1-2016

Journal

International Journal of Cancer

Volume

138

Issue

7

First Page

1785

Last Page

1791

URL with Digital Object Identifier

10.1002/ijc.29905

Abstract

Little is known about the impact of enrollment on therapeutic clinical trials on adverse event rates. Primary objective was to describe the impact of clinical trial registration on sterile site microbiologically documented infection for children with newly diagnosed acute myeloid leukemia (AML). We conducted a multicenter cohort study that included children aged ≤18 years with de novo AML. Primary outcome was microbiologically documented sterile site infection. Infection rates were compared between those registered and not registered on clinical trials. Five hundred seventy-four children with AML were included of which 198 (34.5%) were registered on a therapeutic clinical trial. Overall, 400 (69.7%) had at least one sterile site microbiologically documented infection. In multiple regression, registration on clinical trials was independently associated with a higher risk of microbiologically documented sterile site infection [adjusted odds ratio (OR) 1.24, 95% confidence interval (CI) 1.01-1.53; p = 0.040] and viridans group streptococcal infection (OR 1.46, 95% CI 1.08-1.98; p = 0.015). Registration on trials was not associated with Gram-negative or invasive fungal infections. Children with newly diagnosed AML enrolled on clinical trials have a higher risk of microbiologically documented sterile site infection. This information may impact on supportive care practices in pediatric AML.