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

Irene Kuepfer, Caecilia Schmid, Mpairwe Allan, Andrew Edielu, Emma P Haary, Abbas Kakembo, Stafford Kibona, Johannes Blum and Christian Burri

PLOS Neglected Tropical Diseases, 2012, vol. 6, issue 8, 1-11

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

Date: 2012
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pntd00:0001695

DOI: 10.1371/journal.pntd.0001695

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