Artesunate: link in fighting malaria
One million African children die from severe malaria each year. Intravenous
quinine is currently used to treat the disease, despite several side effects
and poor toleration rates. An alternative treatment, intravenous artesunate,
is now recommended by the World Health Organization for adults in low transmission
areas. In fact, in some Asian countries, artemisinin-based treatments are already
used in preference to quinine. An international consortium will shortly undertake
a phase II clinical trial to evaluate the efficacy of intravenous artesunate
in affected children in high transmission areas, such as Africa.
Funded by the European and Developing Countries Clinical Trials Partnership, (EDCTP) in collaboration with Medicines for Malaria Venture (MMV), the EUR 5.3 million trial is a culmination of activity by European and international organisations in pursuit of better treatments for malaria.
|A new trial will evaluate the
efficacy of IV artesunate against Plasmodium falciparum parasites in
As a partnership between 14 European Union Member States (as well as Norway and Switzerland) and 47 sub-Saharan African countries, EDCTP aims to reduce poverty by developing new clinical interventions to fight HIV/AIDS, malaria and tuberculosis.
EDCTP Executive Director Professor Charles Mgone says, 'The most rational and effective way to combat a serious problem such as malaria in Africa is to combine all available resources. Working in collaboration with MMV, EDCTP is supporting this partnership of European and African scientists to find a safe, affordable and accessible treatment for malaria in children.'
The aims of the trial are twofold: firstly, to increase the body of evidence for the use of intravenous artesunate in children in high transmission areas and show that the use of the potentially more toxic intravenous quinine can be avoided; and secondly, to simplify the dosing regimen of intravenous artesunate from five to three injections.
'If we can show superior efficacy and/or safety and tolerability of the new artesunate regimen in African children,' says MMV Chief Scientific Officer Dr J Carl Craft, 'we are likely to see a major policy change in the treatment of severe malaria in African children.'
After seven years of operation, the non-profit MMV is managing several projects in different stages of research and development, of which three new artemisinin combination therapies have completed phase III clinical trials and are ready for registration. 'IV artesunate has the potential to save countless young lives,' says Dr Craft.
The trial will take place in September 2007 at the Albert Schweitzer Hospital in Lambaréné and the Université de Médecine et Science de la Santé in Gabon, and at the Queen Elizabeth Central Hospital in Blantyre, Malawi. MMV is responsible for the trial's administration, and will finance the monitoring, data management as well as analysis of the study. The trial has received approval from ethics committees and national regulatory authorities in Gabon and Malawi.
European and Developing Countries Clinical Trials Partnership
Medicines for Malaria Venture