CLINICAL-TRIAL OF SPARFLOXACIN FOR LEPROMATOUS LEPROSY

Nine previously untreated patients with lepromatous leprosy were treat ed with 200 mg of sparfloxacin daily for 12 weeks to determine whether this drug is bactericidal for Mycobacterium leprae in humans. The eff icacy of therapy was monitored both clinically and by measuring change s in morphological index, mouse footpad infectivity, and the radioresp irometric activity of M. leprae organisms obtained from serial biopsy specimens and also by determining titers of phenolic glycolipid-I in s erum. Most patients showed clinical improvement within 2 weeks of trea tment; this was accompanied by significant reductions in the morpholog ical index, mouse footpad infectivity, and bacillary radiorespirometri c activity. After 4 weeks of treatment, all patients had a morphologic al index of zero and specimens from most patients were noninfectious f or mice, while the median decrease in radiorespirometric activity was >99%. Overall results by the rapid radiorespirometric assay paralleled those of the mouse footpad and morphological index assays. Sparfloxac in given at 200 mg once daily appears to be rapidly bactericidal in hu mans, with activity similar to that observed in a previous clinical tr ial with 400 m of ofloxacin.