title: Efficacy of itraconazole prophylaxis for autologous stem cell transplantation in children with high-risk solid tumors: a prospective double-blind randomized study.
abstract: OBJECTIVE
  The risk of invasive fungal infection is greater for allogeneic hematopoietic stem cell transplantation (HSCT) than for autologous transplantation. Therefore, many transplantation centers use antifungal prophylaxis for allogeneic HSCT, however, there exists no standard guidelines or consensus regarding autologous HSCT.
  
  
  METHODS
  A prospective double-blind randomized study was conducted in autologous HSCT recipients who were divided into prophylaxis and empirical treatment groups, and we investigated the efficacy of itraconazole prophylaxis in pediatric autologous HSCT.
  
  
  RESULTS
  Total 87 autologous HSCT episodes in 55 children with high-risk solid tumors were studied. No invasive fungal infections occurred in either group. However, patients in the prophylaxis group had a significantly shorter duration of fever (p < 0.05) and received antibacterial treatment of shorter duration (p < 0.05) with fewer numbers of antibiotics (p < 0.05 for the use of second line antibiotics) than those in the empirical group. No significant additional adverse events were found with itraconazole prophylaxis.
  
  
  CONCLUSIONS
  Although beneficial effects such as a shorter duration of fever and reduced need for antibiotic use were observed in the prophylaxis group, the results were not sufficient to draw a definite recommendation about the routine use of antifungal prophylaxis in pediatric autologous HSCT recipients with high-risk solid tumors (Trial registration: NCT00336531).
authors.affiliation: Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong, Gangnam-gu, Seoul 135-710, Korea.
authors.forename: Yae-Jean
authors.initials: YJ
authors.lastname: Kim
authors.forename: Ki Woong
authors.initials: KW
authors.lastname: Sung
authors.forename: Hye Sook
authors.initials: HS
authors.lastname: Hwang
authors.forename: Shin Han
authors.initials: SH
authors.lastname: Jung
authors.forename: Ju Youn
authors.initials: JY
authors.lastname: Kim
authors.forename: Eun Joo
authors.initials: EJ
authors.lastname: Cho
authors.forename: Su Jin
authors.initials: SJ
authors.lastname: Lim
authors.forename: Young Bae
authors.initials: YB
authors.lastname: Choi
authors.forename: Hee Won
authors.initials: HW
authors.lastname: Cheuh
authors.forename: Soo Hyun
authors.initials: SH
authors.lastname: Lee
authors.forename: Keon Hee
authors.initials: KH
authors.lastname: Yoo
authors.forename: Hong Hoe
authors.initials: HH
authors.lastname: Koo
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000935:Antifungal Agents / Q000627:therapeutic use*; D002675:Child, Preschool; D003362:Cost-Benefit Analysis; D004311:Double-Blind Method; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects*; D006801:Humans; D017964:Itraconazole / Q000627:therapeutic use*; D009181:Mycoses / Q000517:prevention & control*; D009369:Neoplasms / Q000601:surgery*; D011446:Prospective Studies; D012307:Risk Factors; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D000935:Antifungal Agents; D017964:Itraconazole