Safety and efficacy of the 10-day melarsoprol schedule for the treatment of second stage Rhodesiense sleeping sickness.
<h4>Objective</h4>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.<h4>Design</h4>Sequential con...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2012-08-01
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| Series: | PLoS Neglected Tropical Diseases |
| Online Access: | https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0001695&type=printable |
| Summary: | <h4>Objective</h4>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.<h4>Design</h4>Sequential conduct of a proof-of-concept trial (n = 60) and a utilization study (n = 78) using historic controls as comparator.<h4>Setting</h4>Two trial centres in the T.b. rhodesiense endemic regions of Tanzania and Uganda.<h4>Participants</h4>Consenting patients with confirmed second stage disease and a minimum age of 6 years were eligible for participation. Unconscious and pregnant patients were excluded.<h4>Main outcome measures</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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.<h4>Trial registration</h4>Current Controlled Trials ISRCTN40537886. |
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| ISSN: | 1935-2727 1935-2735 |