Antibiotic Prophylaxis with Gyrase Inhibitors during Cytostatically Induced Granulocytopenias in Patients with Solid Tumors: A Double-Blind Prospective Randomized Study

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Abstract
Background: Neutropenic patients with solid tumors after cytostatic treatment are often seen in the daily oncological practice. Infections in patients with severe granulocytopenia often have a fatal outcome. Therefore a double-blind study was carried out to examine the efficacy of antibiotic prophylaxis with ofloxacin in cytostatically induced granulocytopenia. Patients and Methods: 80 patients with solid tumors, who had undergone aggressive chemotherapy and in whom granulocytes had fallen to below 500/mm3, were entered into the study. The 80 patients received the gyrase inhibitor ofloxacin or a placebo product in a double-blind randomized study. Results: 2 patients in the ofloxacin group had a temperature above 38 °C compared with 13 patients in the placebo group. In 8 of the 15 febrile episodes there was bacteriological evidence of infection. No side effects attributable to the medication studied were noted. 2 patients in the placebo group, who had already been in a debilitated state because of their tumor, died as a consequence of septicemia. Conclusions: (1) The number of infections or of febrile episodes was significantly less in the ofloxacin group. (2) No death due to septicemia occurred in the ofloxacin group. (3) The therapy costs, including the stay in hospital, for the ofloxacin group were one fifth of those for the placebo group. (4) It can be assumed that the organism responsible for the infections or attacks of fever in the ofloxacin group is resistant to the prophylactic antibiotic. As a rule, they are gram-positive organisms or enterococci. It is thus possible after ofloxacin to initiate antibiotic therapy which is to some extent targeted without identifying the organism. Viewed overall, antibiotic prophylaxis of therapeutically induced granulocytopenia with ofloxacin or an antibiotic with a similarly wide spectrum is effective, of good value and thus very worthy of recommendation.

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