Effectiveness of a 10-Day Melarsoprol Schedule for the Treatment of Late-Stage Human African Trypanosomiasis: Confirmation from a Multinational Study (Impamel II)

• Published in: The Journal of infectious diseases Vol. 191; no. 11; pp. 1922 - 1931
• Main Authors: Schmid, Caecilia, Richer, Michaleen, Bilenge, Constantin Miaka Mia, Josenando, Théophile, Chappuis, Francois, Manthelot, Claude R, Nangouma, Auguste, Doua, Félix, Asumu, Pedro N, Simarro, Pere P, Burri, Christian
• Format: Journal Article
• Language: English
• Published: United States The University of Chicago Press 01-06-2005; University of Chicago Press; Oxford University Press
• Subjects: Adolescent; Adult; African trypanosomiasis; Aged; Aged, 80 and over; Cerebrospinal fluid; Child; Child, Preschool; Dosage; Drug Administration Schedule; Female; Fever; Headache; Humans; Infant; Male; Medical treatment failures; Melarsoprol - therapeutic use; Middle Aged; Parasites; Pruritus; Symptoms; Time Factors; Trypanocidal Agents - therapeutic use; Trypanosome; Trypanosomiasis; Trypanosomiasis, African - drug therapy
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1086/429929

BackgroundTreatment 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 MethodsA 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 ResultsThe 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 ConclusionsThe 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