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 ofloxacingroup 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.
RCT Entities:
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: Wei Li; Rama M Sakamuri; Danielle E Lyons; Florenda M Orcullo; Vidyagouri Shinde; Edred Lao Dela Pena; Armi A Maghanoy; Irene B Mallari; Esterlina V Tan; Indira Nath; Patrick J Brennan; Marivic Balagon; Varalakshmi Vissa Journal: Antimicrob Agents Chemother Date: 2011-08-22 Impact factor: 5.191
Authors: M S Duthie; M N Hay; E M Rada; J Convit; L Ito; L K M Oyafuso; M I P Manini; I M B Goulart; J Lobato; L R Goulart; D Carter; S G Reed Journal: Eur J Clin Microbiol Infect Dis Date: 2011-05-05 Impact factor: 3.267
Authors: Maria Lazo-Porras; Gabriela J Prutsky; Patricia Barrionuevo; Jose Carlos Tapia; Cesar Ugarte-Gil; Oscar J Ponce; Ana Acuña-Villaorduña; Juan Pablo Domecq; Celso De la Cruz-Luque; Larry J Prokop; Germán Málaga Journal: BMC Infect Dis Date: 2020-01-20 Impact factor: 3.090