Safety and Efficacy of the 10-Day Melarsoprol Schedule for the Treatment of Second Stage Rhodesiense Sleeping Sickness
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Date
2012
Journal Title
Journal ISSN
Volume Title
Publisher
PLoS Neglected Tropical Diseases
Abstract
Objective: Assessment of the safety and efficacy of a 10-day melarsoprol schedule in second stage T.b. rhodesiense patients
and the effect of suramin-pretreatment on the incidence of encephalopathic syndrome (ES) during melarsoprol therapy.
Design: Sequential conduct of a proof-of-concept trial (n = 60) and a utilization study (n = 78) using historic controls as
comparator.
Setting: Two trial centres in the T.b. rhodesiense endemic regions of Tanzania and Uganda. Participants: Consenting patients
with confirmed second stage disease and a minimum age of 6 years were eligible for participation. Unconscious and
pregnant patients were excluded.
Main Outcome Measures: The primary outcome measures were safety and efficacy at end of treatment. The secondary
outcome measure was efficacy during follow-up after 3, 6 and 12 months.
Results: The incidence of ES in the trial population was 11.2% (CI 5–17%) and 13% (CI 9–17%) in the historic data. The
respective case fatality rates were 8.4% (CI 3–13.8%) and 9.3% (CI 6–12.6%). All patients discharged alive were free of
parasites at end of treatment. Twelve months after discharge, 96% of patients were clinically cured. The mean
hospitalization time was reduced from 29 to 13 days (p,0.0001) per patient.
Conclusions: The 10-day melarsoprol schedule does not expose patients to a higher risk of ES or death than does treatment
according to national schedules in current use. The efficacy of the 10-day melarsoprol schedule was highly satisfactory. No
benefit could be attributed to the suramin pre-treatment.
Description
Keywords
Melarsoprol Schedule, Treatment, Rhodesiense Sleeping Sickness
Citation
Kuepfer I, Schmid C, Allan M, Edielu A, Haary EP, et al. (2012) Safety and Efficacy of the 10-Day Melarsoprol Schedule for the Treatment of Second Stage Rhodesiense Sleeping Sickness. PLoS Negl Trop Dis 6(8): e1695. doi:10.1371/journal.pntd.0001695