Efficacy of a ten day course of ceftriaxone compared to a shortened five day course in the treatment of community-acquired pneumonia in hospitalized adults with risk factors

OBJECTIVE: This multicenter, randomized, double blind trial was designed to compare the efficacy of a conventional 10D course of ceftriaxone injections (1 g/d) versus a shorter 5D course in the treatment of community-acquired pneumonia (CAP). PATIENTS AND METHOD: Two hundred and fourty four risk patients admitted to hospital for an intended duration of at least 5D were included in the study after chest-X-ray assessment. The primary criterion of success was defined by apyrexia on D10 without resorting to another antibiotic before D10. Secondary criteria included clinical normalization at D10, cure (clinical and radiological) at D30/45, and the absence of another antibiotic intake before D30/45. RESULTS: Baseline demographic data, diagnostic and radiological criteria, co-morbidities and risk-factors were comparable in both groups. Bacteriological assessment was positive for 35.2% of the patients, with 32.6% of pneumococci. Among the 186 patients of the per protocol population, success was assessed at D10 for 77/94 (81.9%) of the patients in the 5D group, and for 76/92 (82.6%) in the 10D group. Clinical normalization at D10 reached 90.1% in the 5D group and 93.1% in the 10D group while the cure rate at D30/45 reached 73.4% in the 5D group and 72.8% in the 10D group. CONCLUSION: Considering all these parameters, the equivalence of clinical efficacy between both treatment regimen was established since the limits of the 95% confidence interval of the success rate difference between both groups were lower than the 10% threshold of acceptable difference defined a priori.