The efficacy of a four-week, ofloxacin-containing regimen compared with standard WHO-MDT in PB leprosy.

Abstract

OBJECTIVES:

To compare the efficacy of a 4-week ofloxacin-containing regimen and the standard WHO-MDT regimen for PB leprosy, in terms of the rate and timing of relapse after treatment completion.

DESIGN:

124 PB patients were enrolled in a randomised, double-blind trial. Of these, 66 received the standard 6-month WHO-MDT regimen, whereas 58 received 28 daily supervised doses of rifampicin 600mg + ofloxacin 400 mg, plus 5 months of placebo. Patients were regularly monitored for clinical response and for signs of relapse after treatment completion.

RESULTS:

Patients enrolled in the ofloxacin group had a mean follow-up of 10.8 years (628 patient-years) with 1 early relapse at 3 years after treatment completion. On relapse, this patient remained smear negative but was reclassified by current WHO criteria (> or =6 skin lesions) as multibacillary (MB). Patients on the WHO-MDT regimen had a mean follow-up of 11.3 years (749 patient-years) with two late relapses at 8 and 12 years, both still classified as PB on relapse.

CONCLUSION:

In conclusion, both regimens appeared generally efficacious, and, in particular, resulted in few relapses.

• Authors: Marivic F Balagon, Roland V Cellona, Rodolfo M Abalos, Robert H Gelber, Paul R Saunderson
• Journal: Leprosy review (Lepr Rev) Vol. 81 Issue 1 Pg. 27-33 (Mar 2010) ISSN: 0305-7518 [Print] England
• PMID: 20496567 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Leprostatic Agents
• Dapsone
• Ofloxacin
• Rifampin

Topics

• Adult
• Dapsone (therapeutic use)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Follow-Up Studies
• Humans
• Leprostatic Agents (therapeutic use)
• Leprosy, Paucibacillary (drug therapy)
• Male
• Middle Aged
• Ofloxacin (therapeutic use)
• Recurrence
• Rifampin (therapeutic use)
• Skin (microbiology)
• Time Factors
• Treatment Outcome
• World Health Organization