Sponsor

Additional Info

Poster on Impamel I/II:

Impamel II

Improved application for melarsoprol, effectiveness in the field

 

The treatment of late-stage human African trypanosomiasis with melarsoprol can be substantially improved by abridging the treatment regimen. Researchers at STI had demonstrated in a large-scale controlled clinical trial (IMPAMEL I) the non-inferiority of a new 10-day treatment schedule for melarsoprol. In the view of changing recommendations and harmonising the treatment with melarsoprol in the endemic countries, an assessment of the effectiveness of the 10-day schedule under true field conditions was crucial.


Therefore, we conducted a multinational / multicentre drug utilisation study in collaboration with national sleeping sickness control programs, WHO and NGOs in several African countries from 1999-2004 (IMPAMEL II program). 2800 patients were treated with the 10-day schedule in 16 treatment centres of 7 African countries. The outcome was assessed based on the major adverse events and the cure rate after the treatment and a 2 years follow-up period.


Generally, the acceptance of the new schedule and the compliance with the study protocol was very high. Safety and efficacy were in the expected range and comparable to previous findings, however, showed a large variation between the treatment centres. We found the 10-day treatment schedule to be more cost-effective than the standard treatment and not surprisingly, the shorter course was well accepted by the patients and the treating staff through its practical application (easy implementation, no dose adjustments, shortened treatment) and the apparent socio-economic advantages (shorter hospitalisation, less drug per patient, cheaper, increased hospital capacity).
Based on our findings and the experience of the sleeping sickness control programs in the respective countries, the abridged protocol was recommended by the 27th ISCTRC in late 2003 as the standard schedule for melarsoprol treatment of late-stage sleeping sickness due to T.b. gambiense.


However, the use of the melarsoprol 10-day schedule against T.b. rhodesiense is currently still strongly discouraged. The clinical nature of this form is very different and high parasitaemia is observed. Confirmation of the clinical evaluation of the 10-day schedule for rhodesiense sleeping sickness still has to be performed.