BACTERICIDAL ACTIVITY OF SINGLE-DOSE OF CLARITHROMYCIN PLUS MINOCYCLINE, WITH OR WITHOUT OFLOXACIN, AGAINST MYCOBACTERIUM-LEPRAE IN PATIENTS

Fifty patients with newly diagnosed lepromatous leprosy were allocated randomly to one of five groups and treated with either a month-long s tandard regimen of multidrug therapy (MDT) for multibacillary leprosy, a single dose of 600 mg of rifampin, a month-long regimen with the da psone (DDS) and clofazimine (CLO) components of the standard MDT, or a single dose of 2,000 mg of clarithromycin (CLARI) plus 200 mg of mino cycline (MINO), with or without the addition of 800 mg of ofloxacin (O FLO), At the end of I month, clinical improvement accompanied by signi ficant decreases of morphological indexes in skin smears was observed in about half of the patients of each group, A significant bactericida l effect was demonstrated in the great majority of patients in all fiv e groups by inoculating the footpads of mice with organisms recovered from biopsy samples obtained before and after treatment, Rifampin prov ed to be a bactericidal drug against Mycobacterium leprae more potent than any combination of the other drugs, A single dose of CLARI-MINO, with or without OFLO, displayed a degree of bactericidal activity simi lar to that of a regimen daily of doses of DDS-CLO for 1 month, sugges ting that it may be possible to replace the DDS and CLO components of the MDT with a monthly dose of CLARI-MINO, with or without OFLO, Howev er, gastrointestinal adverse events were quite frequent among patients treated with CLARI-MINO, with or without OFLO, and mag be attributed to the higher dosage of CLARI or MINO or to the combination of CLARI-M INO plus OFLO, In future trials, therefore, we propose to reduce the d osages of the drugs to 1,000 mg of CLARI, 100 mg of MINO, and 400 mg o f OFLO.