OFLOXACIN multicentre trial in MB leprosy FUAM-Manaus and ILSL-Bauru, Brazil.
Recently antimicrobials of the fluoroquinolone class (pefloxacin and ofloxacin) were found far more effective against Mycobacterium leprae in studies with both mice and patients than dapsone and clofazimine. As multicentre trial participants, we evaluated the therapeutic efficacy, in terms of rate of relapse, of two new multidrug regimens containing ofloxacin, comparing them to 1 year and 2 years of standard WHO-MDT regimen in multibacillary (MB) leprosy patients. A total of 198MB patients were recruited to participate in a randomized, double-blind trial. Among those, 53 patients were treated with 1 year of WHO-MDT (a regimen including dapsone, clofazimine, and rifampin), 55 patients received 1 year of WHO-MDT plus an initial 1 month of daily ofloxacin, 63 patients were treated with 1 month of daily rifampin and daily ofloxacin, whereas 27 were treated with 2 years of WHO-MDT. Patients were regularly monitored for signs of relapse, in at least 7 years follow-up after being released from treatment.


RESULTS
Relapse occurred in those treated with 1-month regimen alone at a significant higher rate (P < 0.001): 388%, whereas in the other three regimens that included WHO-MDT it ranged from 0 to 5%. This study found that a short-course treatment for MB patients with rifampicin-ofloxacin combination had a higher failure rate. The addition of one month of daily ofloxacin to 12 months MB WHO-MDT did not increase its efficacy.
Fundaçäo de Dermatologia Tropical Alfredo da Matta (FUAM), Manaus, Amazonas, Brazil. mcunha@fuam.am.gov.br
Maria Da Graça Souza
Mda G
Cunha
Marcos
M
Virmond
Antonio Pedro
AP
Schettini
Rossilene Conceição
RC
Cruz
Somei
S
Ura
Cassio
C
Ghuidella
Francisco Dos Reis
Fdos R
Viana
João Carlos Regazzi
JC
Avelleira
Antônio A Augusto
AA
Campos
Brasil
B
Filho
D000293:Adolescent; D000328:Adult; D000818:Animals; D001938:Brazil / Q000453:epidemiology; D002991:Clofazimine / Q000494:pharmacology / Q000627:therapeutic use; D003622:Dapsone / Q000494:pharmacology / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007917:Leprostatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D056006:Leprosy, Multibacillary / Q000188:drug therapy* / Q000453:epidemiology / Q000382:microbiology; D008297:Male; D051379:Mice; D008875:Middle Aged; D009166:Mycobacterium leprae / Q000187:drug effects*; D015242:Ofloxacin / Q000009:adverse effects / Q000627:therapeutic use*; D015995:Prevalence; D012293:Rifampin / Q000494:pharmacology / Q000627:therapeutic use; D055502:Secondary Prevention; D012867:Skin / Q000382:microbiology; D013997:Time Factors; D016896:Treatment Outcome; D014944:World Health Organization; D055815:Young Adult
D007917:Leprostatic Agents; D003622:Dapsone; D015242:Ofloxacin; D002991:Clofazimine; D012293:Rifampin