Comparing gatifloxacin and clarithromycin in pneumonia symptom resolution and process of care.

In looking for outcome differences beyond rates of cure, we prospectively compared the symptom resolution, side effects, and processes of care between the use of clarithromycin and gatifloxacin for the treatment of radiographically confirmed community-acquired pneumonia. We conducted a multicenter, randomized, open-label study comparing gatifloxacin monotherapy to clarithromycin alone or combined with ceftriaxone for patients with multiple risk factors. We measured the return to usual activities and symptoms over seven interviews ending 42 days after randomization. Admission and hospital discharge decision support were provided to treating physicians. We enrolled 266 patients over the age of 18 years between September 2000 and June 2003. The groups were similar in age and gender, with a mean age of 53.5+/-19.4 years, and were 54% female. Patient severity as determined by the number of risk factors and the Pneumonia Severity Index was similar between groups; 95% of the patients were low risk. A total of 91% of patients completed at least five of seven symptom interviews. In the clarithromycin study arm, 64% received concomitant therapy with ceftriaxone. We found no significant difference in return to usual activities, pneumonia-specific symptom scores, and 12-item short-form health survey scores. Individual symptom scores were similar except for bad taste and injection site soreness, which were higher in clarithromycin patients. The rates of hospital admission and length of stay were similar. The cost of antibiotic was higher in the clarithromycin group: $257 versus $110 for gatifloxacin. We found that gatifloxacin monotherapy is similar to clarithromycin given with or without ceftriaxone for the treatment of community-acquired pneumonia, except that antibiotic cost, bad taste, and injection site soreness favor the use of gatifloxacin.

RCT Entities:   Population Interventions Outcomes