Safety and Efficacy of the 10-Day Melarsoprol Schedule for the Treatment of Second Stage Rhodesiense Sleeping Sickness

dc.contributor.authorKuepfer, Irene
dc.contributor.authorSchmid, Caecilia
dc.contributor.authorAllan, Mpairwe
dc.contributor.authorEdielu, Andrew
dc.contributor.authorHaary, Emma P.
dc.contributor.authorKakembo, Abbas
dc.contributor.authorKibona, Stafford
dc.contributor.authorBlum, Johannes
dc.contributor.authorBurri, Christian
dc.date.accessioned2022-01-20T23:00:46Z
dc.date.available2022-01-20T23:00:46Z
dc.date.issued2012
dc.description.abstractObjective: 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.en_US
dc.identifier.citationKuepfer 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.0001695en_US
dc.identifier.other10.1371/journal.pntd.0001695
dc.identifier.urihttps://nru.uncst.go.ug/xmlui/handle/123456789/1373
dc.language.isoenen_US
dc.publisherPLoS Neglected Tropical Diseasesen_US
dc.subjectMelarsoprol Scheduleen_US
dc.subjectTreatmenten_US
dc.subjectRhodesiense Sleeping Sicknessen_US
dc.titleSafety and Efficacy of the 10-Day Melarsoprol Schedule for the Treatment of Second Stage Rhodesiense Sleeping Sicknessen_US
dc.typeArticleen_US
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