Effectiveness of a 10-day melarsoprol schedule for the treatment of late-stage human African trypanosomiasis: confirmation from a multinational study (IMPAMEL II).

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.

• 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)

Chemical References

• Trypanocidal Agents
• Melarsoprol

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)