SPARFLOXACIN VERSUS CEFACLOR IN THE TREATMENT OF PATIENTS WITH COMMUNITY-ACQUIRED PNEUMONIA - A RANDOMIZED, DOUBLE-MASKED, COMPARATIVE, MULTICENTER STUDY

Community-acquired pneumonia remains an important infectious disease p roblem, with more than 4 million cases occurring in the United States annually. Although Streptococcus pneumoniae remains the most commonly identified organism, a variety of bacterial and nonbacterial pathogens may be involved. Hospitalization is unnecessary in most cases, and or al antibiotic therapy is common. In the majority of cases, the etiolog y of pneumonia is unknown at the time of presentation, necessitating t he use of empiric therapy. Quinolones have not been utilized in this s etting in the past because of their inconsistent coverage of S pneumon iae. Sparfloxacin (RP 64206) is a broad-spectrum fluoroquinolone with excellent activity in vitro against the majority of bacteria involved in community-acquired pneumonia, including pneumococcus. We therefore studied the efficacy and safety of sparfloxacin compared with the seco nd-generation cephalosporin cefaclor as empiric therapy for patients w ith community-acquired pneumonia in a double-masked, double-dummy, mul ticenter trial. Three hundred thirty patients aged 18 years or older w ith community-acquired pneumonia suspected of being bacterial in etiol ogy were enrolled at 74 centers in the United States from June 1, 1992 , to March 4, 1995. Patients meeting the inclusion criteria were rando mized to receive 10 days of either sparfloxacin 400 mg orally once fol lowed by sparfloxacin 200 mg orally daily (n = 168), or cefaclor 500 m g orally every 8 hours (n = 162). There were no significant difference s between groups with regard to baseline characteristics. Patients wer e followed up serially at 4 a 1 days, 20 +/- 3 days, and 38 +/- 7 days after the beginning of therapy. Patients were evaluated for clinical response, clinical recurrence of infection, and eradication of baselin e pathogens. The primary efficacy variable was the clinical response ( cured or improved) in the subgroup of patients meeting the definition of clinically assessable. Responses were also evaluated in the intent- to-treat population. In the intent-to-treat population, 35.7% of patie nts receiving sparfloxacin were clinically cured, compared with 32.1% of patients receiving cefaclor. Clinical successes (patients clinicall y cured plus improved) were also comparable (72.6% of patients in the sparfloxacin group and 71.0% of patients in the cefaclor group). Simil ar clinical success rates were noted using only the clinically assessa ble population (primary efficacy variable). Forty-four percent of pati ents receiving sparfloxacin and 39.1% of patients receiving cefaclor w ere clinically cured. In the sparfloxacin group, 86.6% of patients wer e clinical successes, compared with 84.4% of patients in the cefaclor group. Microbiologic cures were comparable in both groups. There was n o difference in the incidence of recurrence of infection or superinfec tion. Adverse events thought to be due to study drug occurred equally in both groups (14.3% in the sparfloxacin group vs 14.8% in the cefacl or group). Results show that sparfloxacin is a safe and effective empi ric therapy for patients with community-acquired pneumonia and is comp arable to cefaclor.