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Blood, Vol. 93 No. 10 (May 15), 1999:
pp. 3267-3275
Influence of Intestinal Bacterial Decontamination Using
Metronidazole and Ciprofloxacin or Ciprofloxacin Alone on the
Development of Acute Graft-Versus-Host Disease After Marrow
Transplantation in Patients With Hematologic Malignancies: Final
Results and Long-Term Follow-Up of an Open-Label Prospective
Randomized Trial
Dietrich W. Beelen,
Ahmet Elmaagacli,
Karl-Dieter Müller,
Herbert Hirche, and
Ulrich W. Schaefer
From the Departments of Bone Marrow Transplantation, Medical
Microbiology, and Medical Informatics, Biometry and Epidemiology,
University Hospital of Essen, Essen, Germany.
In a single-center open-label prospective study, a total of 134 marrow transplant recipients with hematologic malignancies were
randomly assigned to a bacterial decontamination medication using
metronidazole and ciprofloxacin (n = 68) or ciprofloxacin alone (n
= 66) during 5 weeks posttransplant. The development of grades II to
IV acute graft-versus-host disease (GVHD) was defined as the primary
study endpoint. According to the intention-to-treat, 17 patients (25%)
randomized to the combined decontamination medication and 33 patients
(50%) randomized to ciprofloxacin alone developed grades II to IV GVHD
(P < .002). The higher frequency of grades II to IV acute
GVHD in patients randomized to ciprofloxacin alone resulted from a more
than twofold increased number of patients developing liver or
intestinal involvement with acute GVHD compared with patients
randomized to the combined decontamination medication (P < .003). The influence of the study medication on grades II to IV acute
GVHD was significant only in recipients of transplants from
genotypically HLA-identical sibling donors (n = 80), whereas in
recipients of transplants from donors other than HLA-identical siblings
(n = 54), grades II to IV acute GVHD frequencies between the study
arms were not significantly different. The combined decontamination was
associated with a significant reduction of culture growth of intestinal
anaerobic bacteria during 5 weeks posttransplant (P < .00001). In addition, the number of cultures with growth of anaerobic
bacteria (P < .005) as well as the median concentrations of
anaerobic bacteria in the posttransplant period (P < .0001)
were higher in patients contracting grades II to IV acute GVHD. Neither
chronic GVHD nor overall survival was significantly different between
the two study arms. In patients with HLA-identical sibling donors who
were treated in early disease stages, the 5-year survival estimate was
slightly, but not significant, higher after the combined
decontamination medication (60% ± 11%) compared with ciprofloxacin
alone (46% ± 9%). In conclusion, the present study provides
evidence that antimicrobial chemotherapy targeted to intestinal
anaerobic bacteria in marrow transplant recipients significantly
reduces the severity of acute GVHD and supports the theory that the
intestinal anaerobic bacterial microflora plays a role in the
pathogenesis of acute GVHD after human marrow transplantation.
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