Treatment of community-acquired pneumonia in outpatients: Randomized studyof clarithromycin alone versus clarithromycin and cefuroxime

Objective: To evaluate the efficacy of clarithromycin alone in comparison w ith the combination of clarithromycin and cefuroxime in the treatment of no nhospitalized patients with community-acquired pneumonia (CAP) in a Mediter ranean population. Methods: CAP was defined as the acute onset of fever (>3 8 degrees C) with pulmonary opacity on chest roentgenogram. The American Th oracic Society (ATS) criteria (1993) were used to decide on patient hospita lization. Ninety subjects, of whom 53 (59%) were men, with a mean age (+/- SD) of 38 +/- 15 years, were randomized: 45 received clarithromycin 500 mg b.i.d. orally for 14 days (CL group), and 45 received clarithromycin plus c efuroxime 500 mg b.i.d. orally for 7 days (CLCE group). Patients were monit ored with clinical, radiological, and laboratory controls at 3 and 21 days. There were no significant differences between the two groups with regard t o demographic, clinical, physical and laboratory data. Results: The mean ti me to defervescence was 2.4 +/- 1.4 and 2.4 +/- 1.5 days, respectively. Che st roentgenogram clearance was complete in all cases, without statistically significant differences in the time to resolution between both arms. Side effects were mild (no significant differences between groups): 5 patients i n the CL group and 3 in the CLCE group showed gastrointestinal symptoms. Tw o patients (2.2%), both in the CLCE group, needed hospital admission during follow-up, but all 90 patients showed an excellent outcome. A causative ag ent was determined in 25 cases (28%). Legionella pneumophila, Streptococcus pneumoniae, and Mycoplasma pneumoniae were the most frequent pathogens. Co nclusion: Empirical treatment of outpatient CAP with clarithromycin can be considered adequate in the Mediterranean area, independently of the microbi ological etiology. ATS criteria for admitting patients with CAP are appropr iate in this population.