Safety and efficacy of the 10-day melarsoprol schedule for the treatment of second stage Rhodesiense sleeping sickness.


Kuepfer, I; Schmid, C; Allan, M; Edielu, A; Haary, EP; Kakembo, A; Kibona, S; Blum, J; Burri, C; (2012) Safety and efficacy of the 10-day melarsoprol schedule for the treatment of second stage Rhodesiense sleeping sickness. PLoS neglected tropical diseases, 6 (8). e1695. ISSN 1935-2727 DOI: https://doi.org/10.1371/journal.pntd.0001695

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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. TRIAL REGISTRATION Current Controlled Trials ISRCTN40537886.

Item Type: Article
Faculty and Department: Faculty of Infectious and Tropical Diseases > Dept of Disease Control
PubMed ID: 22970329
Web of Science ID: 308497100001
URI: http://researchonline.lshtm.ac.uk/id/eprint/1273102

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