title: Randomized double blind trial of ciprofloxacin prophylaxis during induction treatment in childhood acute lymphoblastic leukemia in the WK-ALL protocol in Indonesia.
abstract: OBJECTIVE
  Toxic death is a big problem in the treatment of childhood acute lymphoblastic leukemia (ALL), especially in low-income countries. Studies of ciprofloxacin as single agent prophylaxis vary widely in success rate. We conducted a double-blind, randomized study to test the effects of ciprofloxacin monotherapy as prophylaxis for sepsis and death in induction treatment of the Indonesian childhood ALL protocol.
  
  
  METHODS
  Patients were randomized to the ciprofloxacin arm (n = 58) and to the placebo arm (n = 52). Oral ciprofloxacin monotherapy or oral placebo was administered twice a day. All events during induction were recorded: toxic death, abandonment, resistant disease, and complete remission rate.
  
  
  RESULTS
  Of 110 patients enrolled in this study, 79 (71.8%) achieved CR. In comparison to the placebo arm, the ciprofloxacin arm had lower nadir of absolute neutrophil count during induction with median of 62 (range: 5-884) versus 270 (range: 14-25,480) × 10(9) cells/L (P < 0.01), greater risks for experiencing fever (50.0% versus 32.7%, P = 0.07), clinical sepsis (50.0% versus 38.5%, P = 0.22), and death (18.9% versus 5.8%, P = 0.05).
  
  
  CONCLUSIONS
  In our setting, a reduced intensity protocol in a low-income situation, the data warn against using ciprofloxacin prophylaxis during induction treatment. A lower nadir of neutrophil count and higher mortality were found in the ciprofloxacin group.
authors: Pediatric Hematology and Oncology Division, Department of Pediatrics, Dr Sardjito Hospital, Medical Faculty, Universitas Gadjah Mada, Yogyakarta, Indonesia.
authors: Pudjo H
authors: PH
authors: Widjajanto
authors: Sumadiono
authors: S
authors: Sumadiono
authors: Jacqueline
authors: J
authors: Cloos
authors: Ignatius
authors: I
authors: Purwanto
authors: Sutaryo
authors: S
authors: Sutaryo
authors: Anjo Jp
authors: AJ
authors: Veerman
keywords: childhood acute lymphoblastic leukemia; ciprofloxacin; low-income country; prophylaxis; randomized trial
references: Lancet. 2003 Aug 30;362(9385):706-8
references: 12957095
references: Eur J Clin Microbiol Infect Dis. 2008 Jan;27(1):53-63
references: 17938978
references: Antimicrob Agents Chemother. 1985 Aug;28(2):331-42
references: 2939797
references: Clin Infect Dis. 2005 Apr 15;40(8):1087-93
references: 15791505
references: Antimicrob Agents Chemother. 1994 Apr;38(4):681-7
references: 8031031
references: Semin Hematol. 2009 Jul;46(3):259-68
references: 19549578
references: Am J Med. 1996 Jan;100(1):17-23
references: 8579082
references: Pediatr Blood Cancer. 2005 Aug;45(2):103-6
references: 15920777
references: Eur J Clin Microbiol Infect Dis. 1998 Aug;17(8):591-2
references: 9796662
references: Cancer. 2003 Jan 15;97(2):419-24
references: 12518366
references: J Antimicrob Chemother. 2004 Jul;54(1):29-37
references: 15201227
references: Br J Haematol. 1976 Aug;33(4):451-8
references: 188440
references: Ann Intern Med. 1966 Feb;64(2):328-40
references: 5216294
references: Infection. 2000 Sep;28(5):278-81
references: 11073133
references: Ann Intern Med. 2005 Jun 21;142(12 Pt 1):979-95
references: 15968013
references: Ann Intern Med. 1996 Aug 1;125(3):183-90
references: 8686975
references: J Clin Oncol. 2005 Jun 20;23(18):4198-214
references: 15961767
references: Clin Infect Dis. 1996 Oct;23(4):795-805
references: 8909847
references: Br J Haematol. 2001 Feb;112(2):293-9
references: 11167821
references: J Clin Oncol. 2000 Oct 15;18(20):3558-85
references: 11032599
references: Leukemia. 2005 Apr;19(4):537-44
references: 15690069
references: J Pediatr Hematol Oncol. 2000 Nov-Dec;22(6):495-501
references: 11132215
references: Antimicrob Agents Chemother. 2004 Jun;48(6):1934-40
references: 15155181
references: N Engl J Med. 1999 Sep 16;341(12):893-900
references: 10486422
references: JAMA. 2004 May 26;291(20):2471-5
references: 15161898
references: J Clin Oncol. 1998 Mar;16(3):1179-87
references: 9508206
references: Infection. 1991 Mar-Apr;19(2):73-80
references: 2050424
references: J Antimicrob Chemother. 1994 Apr;33(4):837-44
references: 8056702
references: Pediatrics. 2006 Dec;118(6):e1600-6
references: 17074838
references: J Antimicrob Chemother. 2008 Mar;61(3):721-8
references: 18218645
references: N Engl J Med. 2005 Sep 8;353(10):977-87
references: 16148283