title: Impact of registration on clinical trials on infection risk in pediatric acute myeloid leukemia.
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.
authors.affiliation: Pediatric Hematology/Oncology, British Columbia Children's Hospital, Vancouver, BC, Canada.
authors.forename: David
authors.initials: D
authors.lastname: Dix
authors.affiliation: Oncology, Children's Hospital of Philadelphia, Philadelphia, PA.
authors.forename: Richard
authors.initials: R
authors.lastname: Aplenc
authors.affiliation: Hematology/Oncology, Janeway Child Health Centre, St. John's, NFLD, Canada.
authors.forename: Lynette
authors.initials: L
authors.lastname: Bowes
authors.affiliation: Hematology/Oncology, Hopital Sainte-Justine, Montreal, QC, Canada.
authors.forename: Sonia
authors.initials: S
authors.lastname: Cellot
authors.affiliation: Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, ON, Canada.
authors.forename: Marie-Chantal
authors.initials: MC
authors.lastname: Ethier
authors.affiliation: Department of Hematology/Oncology, Children's Hospital and Research Center Oakland, Oakland, CA.
authors.forename: Jim
authors.initials: J
authors.lastname: Feusner
authors.affiliation: Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, ON, Canada.
authors.forename: Biljana
authors.initials: B
authors.lastname: Gillmeister
authors.affiliation: Hematology Oncology, Children's Hospital of Eastern Ontario, Otawa, ON, Canada.
authors.forename: Donna L
authors.initials: DL
authors.lastname: Johnston
authors.affiliation: Hematology/Oncology/Transplant Program, Alberta Children's Hospital, Calgary, AB, Canada.
authors.forename: Victor
authors.initials: V
authors.lastname: Lewis
authors.affiliation: Pediatric Hematology/Oncology Centre, Hospitalier Universitaire De Quebec, Laval, QC, Canada.
authors.forename: Bruno
authors.initials: B
authors.lastname: Michon
authors.affiliation: Hematology/Oncology, Montreal Children's Hospital, Montreal, QC, Canada.
authors.forename: David
authors.initials: D
authors.lastname: Mitchell
authors.affiliation: Hematology/Oncology, Chedoke-McMaster Hospitals, Hamilton, ON, Canada.
authors.forename: Carol
authors.initials: C
authors.lastname: Portwine
authors.affiliation: Pediatrics, IWK Health Centre, Halifax, NS, Canada.
authors.forename: Victoria
authors.initials: V
authors.lastname: Price
authors.affiliation: Hematology/Oncology, Cancer Centre of Southeastern Ontario at Kingston, Kingston, ON, Canada.
authors.forename: Mariana
authors.initials: M
authors.lastname: Silva
authors.affiliation: Stollery Children's Hospital, University of Alberta Hospital, Edmonton, AB, Canada.
authors.forename: Kent
authors.initials: K
authors.lastname: Stobart
authors.affiliation: Hematology/Oncology, CancerCare Manitoba, Winnipeg, MB, Canada.
authors.forename: Rochelle
authors.initials: R
authors.lastname: Yanofsky
authors.affiliation: Hematology/Oncology, London Health Sciences, London, ON, Canada.
authors.forename: Shayna
authors.initials: S
authors.lastname: Zelcer
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada.
authors.forename: Joseph
authors.initials: J
authors.lastname: Beyene
authors.affiliation: Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, ON, Canada.
authors.forename: Lillian
authors.initials: L
authors.lastname: Sung
mesh_terms: D000293:Adolescent; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007239:Infections / Q000453:epidemiology*; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy / Q000382:microbiology*; D008297:Male; D012307:Risk Factors
keywords: acute myeloid leukemia; bacteremia; children; clinical trial; infection