[Multicenter open randomized trial of meropenem in comparison to ceftazidime and amikacin used in combination in severe hospital infections]

Abstract

Clinical efficacy and tolerance of meropenem were estimated by comparison with those of ceftazidime and amikacin used in combination in the therapy of hospital infections of the lower respiratory tract, skin and soft tissues, intraabdominal and gynecologic infections, urinary tract infection and sepsis. 48 patients were given meropenem in a dose of 1 g every 8 hours for 3-14 days (the average of 9 days). 47 patients were subjected to the routine combined therapy: ceftazidime in a dose of 1 g every 8 hours and amikacin in a dose of 0.5 g every 12 hours for 2-14 days (the average of 9 days). The patient groups were comparable by the age, nature and severity of the infection and the condition (the mean APACHE II of 9.1 and 8.9). By the end of the treatment a positive clinical effect (recovery and improvement) was observed in 47 patients (97.9 per cent) treated with meropenem and in 41 patients (89.1 per cent) subjected to the combined therapy. The infection relapse within 4 weeks after the treatment completion was recorded in 3 patients in every group. Before the treatment 133 microbial strains were isolated from the patients. 121 of them were susceptible to meropenem (91.1 per cent), 111 to amikacin (83.4 per cent) and 90 to ceftazidime (67.7 per cent). The difference between meropenem and ceftazidime was significant (p = 0.0005). Eradication of the primary pathogens at the background of the meropenem therapy was stated in 41 out of 44 patients (93.2 per cent) and that of the combined therapy in 38 out of 43 patients (88.4 per cent). The microbiological relapse after the treatment completion was recorded in 3 and 2 patients, respectively. Side effects were observed in 8.3 per cent of the patients treated with meropenem and in 10.6 per cent of the patients subjected to the combined therapy. The trial results were indicative of the meropenem high efficacy and good tolerance and of the possible use of the drug in the monotherapy as an alternative of the routine combined therapy of severe hospital infections.