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Impact of registration on clinical trials on infection risk in pediatric acute myeloid leukemia |
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| Authors: | David Dix Richard Aplenc Lynette Bowes Sonia Cellot Marie‐Chantal Ethier Jim Feusner Biljana Gillmeister Donna L. Johnston Victor Lewis Bruno Michon David Mitchell Carol Portwine Victoria Price Mariana Silva Kent Stobart Rochelle Yanofsky Shayna Zelcer Joseph Beyene Lillian Sung |
| Affiliation: | 1. Pediatric Hematology/Oncology, British Columbia Children's Hospital, Vancouver, BC, Canada;2. OncologyChildren's Hospital of Philadelphia, Philadelphia, PA;3. Hematology/Oncology, Janeway Child Health Centre, St. John's, NFLD, Canada;4. Hematology/Oncology, Hopital Sainte‐Justine, Montreal, QC, Canada;5. Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, ON, Canada;6. Department of Hematology/Oncology, Children's Hospital and Research Center Oakland, Oakland, CA;7. Hematology Oncology, Children's Hospital of Eastern Ontario, Otawa, ON, Canada;8. Hematology/Oncology/Transplant Program, Alberta Children's Hospital, Calgary, AB, Canada;9. Pediatric Hematology/Oncology Centre, Hospitalier Universitaire De Quebec, Laval, QC, Canada;10. Hematology/Oncology, Montreal Children's Hospital, Montreal, QC, Canada;11. Hematology/Oncology, Chedoke‐McMaster Hospitals, Hamilton, ON, Canada;12. Pediatrics, IWK Health Centre, Halifax, NS, Canada;13. Hematology/Oncology, Cancer Centre of Southeastern Ontario at Kingston, Kingston, ON, Canada;14. Stollery Children's Hospital, University of Alberta Hospital, Edmonton, AB, Canada;15. Hematology/Oncology, CancerCare Manitoba, Winnipeg, MB, Canada;16. Hematology/Oncology, London Health Sciences, London, ON, Canada;17. Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada;18. Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, ON, Canada |
| 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. |
| Keywords: | infection bacteremia children acute myeloid leukemia clinical trial |