CLINICAL-TRIAL OF CLARITHROMYCIN FOR LEPROMATOUS LEPROSY

Clarithromycin was administered to nine previously untreated lepromato us leprosy patients. Patients received two 1,500-mg doses on the first day, followed by 7 days of no treatment, in order to evaluate the pot ential efficacy of intermittent therapy. Patients then received 1,000 mg daily for 2 weeks followed by 500 mg daily for 9 weeks. The efficac y of therapy was monitored clinically, by changes in morphological ind ex, mouse footpad infectivity, and radiorespirometric activity of Myco bacterium leprae obtained from serial biopsies and by serum levels of phenolic glycolipid I. Clarithromycin was well tolerated, with only mi nor side effects noted in two patients. Most patients showed reduction s in morphological index and radiorespirometry I week after the first two doses. Within 3 weeks of starting treatment (total of 17 g of clar ithromycin), biopsy-derived M. leprae specimens from all patients had a morphological index of zero, were noninfectious for mice, and had le ss than 1% of the radiorespirometric activity of pretreatment specimen s. Reductions in serum phenolic glycolipid I levels were observed for most patients at 3 weeks. Significant clinical improvement was evident after 4 weeks of treatment. All analyses indicate that clarithromycin is rapidly bactericidal for M. leprae in humans.