PROSPECTIVE RANDOMIZED STUDY TO COMPARE IMIPENEM 1.5 GRAMS PER DAY VS. 3.0 GRAMS PER DAY IN INFECTIONS OF GRANULOCYTOPENIC PATIENTS

The objective of this presented prospective randomized study was to co mpare the efficacy of empirical antimicrobial monotherapy with imipene m 3 x 0.5 g per day to 3 x 1.0 g per day for treatment of infections i n neutropenic patients. A total of 192/220 febrile episodes were evalu able for clinical efficacy, The overall response rate was 53/93 (57%) vs. 57/99 (58%), Of the different infection types, fever of unknown or igin (FUO) showed the best response, with defervescence in 29/41 (71%) and 36/42 (86%) cases, respectively (not significant), Unfavourable r esults were found in pneumonias [5/20 (25%) vs. 4/23 (17%)], The media n time until persistent defervescence was equal in both groups (2 days ), likewise the median duration of imipenem therapy in responders (7 d ays). The most frequent micro-organisms were Gram-negative, documented in 22% of the febrile episodes in the lower dosage group os. 17% of a ll episodes in the patients with imipenem 3.0 g per day (Gram-positive s 17% vs. 14%, fungal 5% vs. 8%). In the lower dosage group, fever wit h abdominal symptoms occurred less frequently (8% vs. 15%), and signif icantly more patients tolerated imipenem without any side-effects (95. 8% vs, 79.4%), especially regarding severe nausea/vomiting (2.1% vs. 1 1.8%). Of the initial non-responders, 35/40 (88%) vs, 41/42 (98%) were cured after therapy modification, There was no significant difference in the use of further antibiotics such as aminoglycosides, glycopepti des, ceftazidime or amphotericin B, except a marginally higher use of metronidazole in patients with imipenem 3.0 g per day (3% vs. 10%). Ov erall, we found no significant differences in efficacy between the two study groups, but more frequent side-effects with imipenem 3.0 g per day.