Comparison of levofloxacin (L) and cefotaxime (C) combined with ofloxacin (O) for treatment of severe community-acquired pneumonia (CAP) in the intensive care unit
Abstract
To evaluate, in patients with severe CAP requiring ICU admission, the efficacy and tolerance of L (500 mg/12 hours) given intravenously (+ oral route) during 10–14 days as a monotherapy in comparison with an intravenous combination of C (1 g/8 hours) and O (200 mg/12 hours). Patients included in this phase IV, prospective, multicenter, multinational, open, and randomized (1:1) study exhibited a severe CAP defined by usual criteria. The statistical hypothesis was a noninferiority of L to C + O with a 2.5% a-risk (bilateral) and a 15% maximum set difference. In the modified intent-to-treat and the per-protocol (PP) populations, there were 308 (L: 149; C + O: 159) and 271 patients (L: 139; C + O: 132), respectively. The main patients characteristics were similar in both groups. Mean age = 59.6 ± 16.7 years, male gender = 68.2%. Mean SAPS II values at inclusion were 34.0 ± 15.8 (L) and 33.0 ± 13.7 (C + O). Mechanical ventilation, during the first 2 days of inclusion was required in 53.5% (L) vs 56.2% (C + O) patients. At least one causal organism was identified in 55.0% (L) vs 54.1% patients (C + O). Blood cultures were positive in 24.4% (L) and 22.1% (C + O) documented patients. Streptococcus pneumoniae (47.6% patients) and Haemophilus spp. (23.8% patients) were the predominant pathogens followed by Staphylococcus aureus (6.0%), atypicals (7.1%), and enterobacteriaceae (8.9%). The clinical success rates, at end of treatment, in the PP population were 79.1% (L) vs 79.5% (C + O).…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 395 participants or records.
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