Abstract | BACKGROUND: Treatment of late-stage human African trypanosomiasis (HAT) with melarsoprol can be improved by shortening the regimen. A previous trial demonstrated the safety and efficacy of a 10-day treatment schedule. We demonstrate the effectiveness of this schedule in a noncontrolled, multinational drug-utilization study. METHODS: A total of 2020 patients with late-stage HAT were treated with the 10-day melarsoprol schedule in 16 centers in 7 African countries. We assessed outcome on the basis of major adverse events and the cure rate after treatment and during 2 years of follow-up. RESULTS: The cure rate 24 h after treatment was 93.9%; 2 years later, it was 86.2%. However, 49.3% of patients were lost to follow-up. The overall fatality rate was 5.9%. Of treated patients, 8.7% had an encephalopathic syndrome that was fatal 45.5% of the time. The rate of severe bullous and maculopapular eruptions was 0.8% and 6.8%, respectively. CONCLUSIONS: The 10-day treatment schedule was well implemented in the field and was effective. It reduces treatment duration, drug amount, and hospitalization costs per patient, and it increases treatment-center capacity. The shorter protocol has been recommended by the International Scientific Council for Trypanosomiasis Research and Control for the treatment of late-stage HAT caused by Trypanosoma brucei gambiense.
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Authors | Caecilia Schmid, Michaleen Richer, Constantin Miaka Mia Bilenge, Théophile Josenando, Francois Chappuis, Claude R Manthelot, Auguste Nangouma, Félix Doua, Pedro N Asumu, Pere P Simarro, Christian Burri |
Journal | The Journal of infectious diseases
(J Infect Dis)
Vol. 191
Issue 11
Pg. 1922-31
(Jun 01 2005)
ISSN: 0022-1899 [Print] United States |
PMID | 15871127
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Trypanocidal Agents
- Melarsoprol
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Child
- Child, Preschool
- Drug Administration Schedule
- Female
- Humans
- Infant
- Male
- Melarsoprol
(therapeutic use)
- Middle Aged
- Time Factors
- Trypanocidal Agents
(therapeutic use)
- Trypanosomiasis, African
(drug therapy)
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