Effectiveness of a 10-day melarsoprol schedule for the treatment of late-stage human African trypanosomiasis: confirmation from a multinational study (IMPAMEL II).
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.
Schmid
Caecilia
C
Swiss Tropical Institute, Basel.
Richer
Michaleen
M
Bilenge
Constantin Miaka Mia
CM
Josenando
Théophile
T
Chappuis
Francois
F
Manthelot
Claude R
CR
Nangouma
Auguste
A
Doua
Félix
F
Asumu
Pedro N
PN
Simarro
Pere P
PP
Burri
Christian
C
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008549:Melarsoprol / Q000627:therapeutic use*; D008875:Middle Aged; D013997:Time Factors; D014344:Trypanocidal Agents / Q000627:therapeutic use*; D014353:Trypanosomiasis, African / Q000188:drug therapy*
D014344:Trypanocidal Agents; D008549:Melarsoprol