comparison of levofloxacin and cefotaxime combined with ofloxacin for icu patients with communityacquired pneumonia who do not require vasopressors study objectives to evaluate the efficacy and tolerability of levofloxacin l as monotherapy in patients with severe communityacquired pneumonia cap in comparison with therapy using a combination of cefotaxime c plus ofloxacin odesign prospective randomized 11 comparative open parallelgroup studysetting multinational study with 149 sitespatients a total of 398 randomized patients who had been admitted to the icu with severe cap without shock including 308 patients in a modified intenttotreat population and 271 patients in the perprotocol pp population l group 139 patients c o group 132 patientsinterventions therapy with levofloxacin 500 mg iv q12h vs therapy with a c o combination c 1g iv q8h o 200 mg iv q12h for 10 to 14 daysmeasurements and results the main end point was the clinical efficacy at the end of treatment ie the testofcure toc visit the statistical hypothesis was the noninferiority of l therapy to c o therapy with a 25 alpha risk unilateral and a 15 maximum set difference at the toc visit a clinical success was observed in 791 of patients l group and 795 of patients c o group in the pp population difference 04 95 confidence interval ci 1079 to 997 without adjustment for simplified acute physiology score saps ii at inclusion difference 03 95 ci 1013 to 958 with adjustment for saps ii a satisfactory bacteriologic response was present in 737 of l group patients and 775 of c o group patients including responses of 757 and 703 respectively in the l group and c o group in the streptococcus pneumoniaedocumented population in the safety analysis 20 patients in the l group 103 and 16 patients in the c o group 80 experienced at least one adverse event that was considered to be treatmentrelatedconclusion l therapy was at least as effective as the combination therapy of c o in the treatment of a subset of patients with cap requiring icu admission this conclusion cannot be extrapolated to patients requiring mechanical ventilation or vasopressors ie those patients in shock