BACTERICIDAL ACTIVITY OF A SINGLE-DOSE COMBINATION OF OFLOXACIN PLUS MINOCYCLINE, WITH OR WITHOUT RIFAMPIN, AGAINST MYCOBACTERIUM-LEPRAE INMICE AND IN LEPROMATOUS PATIENTS

To develop a fully supervisable, monthly administered regimen for trea tment of leprosy, the bactericidal effect of a single-dose combination of ofloxacin (OFLO) and minocycline (MINO), with or without rifampin (RMP), against Mycobacterium leprae was studied in the mouse footpad s ystem and in previously untreated lepromatous leprosy patients. Bacter icidal activity was measured by the proportional bactericidal method. In mouse experiments, the activity of a single dose of the combination OFLO-MINO was dosage related; the higher dosage of the combination di splayed bactericidal activity which was significantly inferior to that of a single dose of RMP, whereas the lower dosage did not exhibit a b actericidal effect. In the clinical trial, 20 patients with previously untreated lepromatous leprosy were treated with a single dose consist ing of either 600 mg of RMP plus 400 mg of OFLO and 100 mg of MINO or 400 mg of OFLO plus 100 mg of MINO. The OFLO-MINO combination exhibite d definite bactericidal activity in 7 of 10 patients but,vas less bact ericidal than the RMP-OFLO-MINO combination. Both combinations were we ll tolerated. Because of these promising results, a test of the effica cy of multiple doses of ROM in a larger clinical trial appears justifi ed.