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Randomized trial of the addition of gram-positive prophylaxis to standard antimicrobial prophylaxis for patients undergoing autologous bone marrow transplantation.

Abstract
The purpose of the study reported here was to investigate the impact of prophylaxis against gram-positive infections in patients undergoing high-dose chemotherapy and autologous bone marrow transplantation in a randomized trial. Forty-three patients undergoing high-dose chemotherapy with autologous bone marrow transplant were enrolled in a nonblinded randomized trial to receive or not to receive prophylaxis for gram-positive infections with 10(6) U of penicillin intravenously (i.v.) every 6 h (q6h) (if penicillin allergic, 750 mg of vancomycin i.v. q12h) in addition to standard antimicrobial prophylaxis with 400 mg of norfloxacin orally three times a day, 200 mg of fluconazole orally once a day, and 5 mg of acyclovir per kg of body weight i.v. q12h. The patients were being treated for germ cell cancer (n = 15), breast cancer (n = 16), Hodgkin's disease (n = 3), non-Hodgkin's lymphoma (n = 4), acute myeloid leukemia (n = 1), acute lymphoblastic leukemia (n = 1), and ovarian cancer (n = 3). The trial was stopped because of excess morbidity in the form of streptococcal septic shock in the group not receiving gram-positive prophylaxis. There were significantly fewer overall infections (10 versus 3; P = 0.016) and streptococcal infections (9 versus 1; P = 0.0078) in the group receiving gram-positive prophylaxis. There were no significant differences in the numbers of deaths, duration of broad-spectrum antibiotics, or incidence of neutropenic fever between the two groups. Prophylaxis for gram-positive infections with penicillin or vancomycin is effective in reducing the incidence of streptococcal infections in patients undergoing high-dose chemotherapy and autologous bone marrow transplant. However, this approach may carry a risk of fostering resistance among streptococci to penicillin or vancomycin.
AuthorsE R Broun, J L Wheat, P H Kneebone, K Sundblad, R A Hromas, G Tricot
JournalAntimicrobial agents and chemotherapy (Antimicrob Agents Chemother) Vol. 38 Issue 3 Pg. 576-9 (Mar 1994) ISSN: 0066-4804 [Print] United States
PMID8203857 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
Chemical References
  • Penicillins
  • Vancomycin
  • Fluconazole
  • Norfloxacin
  • Acyclovir
Topics
  • Acyclovir (therapeutic use)
  • Adult
  • Bacteremia (microbiology, prevention & control)
  • Bone Marrow Transplantation
  • Female
  • Fever (prevention & control)
  • Fluconazole (therapeutic use)
  • Gram-Positive Bacterial Infections (microbiology, prevention & control)
  • Humans
  • Male
  • Middle Aged
  • Neoplasms (complications, therapy)
  • Norfloxacin (therapeutic use)
  • Penicillins (administration & dosage, therapeutic use)
  • Premedication
  • Streptococcal Infections (microbiology, prevention & control)
  • Vancomycin (therapeutic use)

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