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Programme de bourses "Echanges Universitaires"

Assessment of efficacy and safety of Artekin, Cartem and SP for the treatment of uncomplicated Plasmodium falciparum malaria in children in Tanzania.

Christian Nsanzabana, University of Neuchâtel (christian.nsanzabana@unine.ch)

Every year, 1.5-2.7 million people worldwide die from malaria, while 300-400 million become infected. 90% of all deaths occur in Africa. The groups suffering most are young children and pregnant women. People who survive a severe malaria attack often suffer permanent development deficits and neurological abnormalities. Malaria’s economic impact is huge, reducing economic growth rate by an estimated 1.3% per year. Malaria has doubled or more in most parts of Africa during past two decades because of the widespread resistance of Plasmodium falciparum to conventional drugs, such as chloroquine, sulfadoxine-pyrimethamine (SP) and amodiaquine. As a result of these trends, many countries have to change their treatment policies and use drugs which are more expensive, including combinations of drugs, which it is hoped will slow the development of resistance.

Over the last decade, a new group of antimalarials have been deployed on an increasingly large scale: the artemisinin compounds, especially artesunate, artemether and dihydroartemisinin. The compounds produce a very rapid therapeutic response, are effective against multi-resistant P. falciaprum malaria, are well tolerated by the patients and reduce gametocyte carriage, thereby having the potential to reduce transmission of malaria. Studies in South East Asia have shown that combinations of artemisinin compounds with another drug yield high cure rates with treatment lasting only three days. Furthermore there is some evidence that such combinations can greatly retard development of resistance the partner drugs.

Because of the diminishing efficacy of SP in East Africa, there is a need to develop and implement strategies to protect drugs against resistance. Alternative drugs must be evaluated for the potential challenges of treating this life-threatening disease in the most vulnerable groups of the African population. For the moment, the combination of artemether and lumefantrine (Coartem) is the only commercially available co-formulated artemisinin-containing combination therapy (ACT) for malaria. Several other Acts are in mid or late phase of development, like Ramekin, a combination of piperaquine and dihydroartemisinin. This drug, only registered in China and Cambodia, has been shown to be highly efficacious against multi-drug resistant parasites and no serious adverse drug reactions have been noted or reported. Moreover this new two-drug fixed combination antimalarial is quite inexpensive, it costs about $ 1 for an adult treatment.

The proposed pilot work is a part of a PhD study, which aims to compare the clinical efficacy and safety of Artekin and Coartem to SP in children under 5 years with symptomatic malaria, and also to assess the Artekin pharmacokinetics and its in vitro activity. This study will concentrate on the evaluation of efficacy and safety of these three drugs in children under 5 years. The study will take place in the Kilombero district in the Morogoro region of southern Tanzania. The efficacy of different regimens in terms of resolution of symptoms present at baseline will be assessed. All comparisons will be made relative to SP as the standard treatment.

Because of its efficacy and relatively low cost , the use of Artekin is likely to increase in the future, but more information about its efficacy in area of intense malaria transmission and its safety in children are needed. This study could be an important step in the international registration of the drug.

Partners institutions:

Université de Neuchâtel
Institut de zoologie
Rue Emile-Argand 11
CH-2007 Neuchâtel
http://www.unine.ch

Christian Nsanzabana
+41-(0)-32-718 30 40
christian.nsanzabana@unine.ch

Prof. Dr. Bruno Betschart
+41-(0)-32-718 30 45
bruno.betschart@unine.ch

Ifakara Health Research and Development Centre (IHRDC)
Off Mlabani Passage
Box 53
Ifakara, Tanzania
http://www.ihrdc.org

Dr. Hassan Mshinda
+255232625164/ +255744
hmshinda@ifakara.mimcom.net

Dr. Salim Abdulla
+255744744555 / +255748744555
salim_abdulla@hotmail.com

Swiss Tropical Institute
Socinstrasse 57
CH-4002 Basel
http://www.sti.ch

Prof. Dr. Marcel Tanner
+41-(0)-26- 284 82 83
marcel.tanner@unibas.ch


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		Home > Projects > Echangesuniv

		Programme de bourses "Echanges Universitaires" *Assessment of efficacy and safety of Artekin, Cartem and SP for the treatment of uncomplicated Plasmodium falciparum* malaria in children in Tanzania*. Christian Nsanzabana, University of Neuchâtel (christian.nsanzabana@unine.ch) Every year, 1.5-2.7 million people worldwide die from malaria, while 300-400 million become infected. 90% of all deaths occur in Africa. The groups suffering most are young children and pregnant women. People who survive a severe malaria attack often suffer permanent development deficits and neurological abnormalities. Malaria’s economic impact is huge, reducing economic growth rate by an estimated 1.3% per year. Malaria has doubled or more in most parts of Africa during past two decades because of the widespread resistance of Plasmodium falciparum* to conventional drugs, such as chloroquine, sulfadoxine-pyrimethamine (SP) and amodiaquine. As a result of these trends, many countries have to change their treatment policies and use drugs which are more expensive, including combinations of drugs, which it is hoped will slow the development of resistance. Over the last decade, a new group of antimalarials have been deployed on an increasingly large scale: the artemisinin compounds, especially artesunate, artemether and dihydroartemisinin. The compounds produce a very rapid therapeutic response, are effective against multi-resistant P. falciaprum malaria, are well tolerated by the patients and reduce gametocyte carriage, thereby having the potential to reduce transmission of malaria. Studies in South East Asia have shown that combinations of artemisinin compounds with another drug yield high cure rates with treatment lasting only three days. Furthermore there is some evidence that such combinations can greatly retard development of resistance the partner drugs. Because of the diminishing efficacy of SP in East Africa, there is a need to develop and implement strategies to protect drugs against resistance. Alternative drugs must be evaluated for the potential challenges of treating this life-threatening disease in the most vulnerable groups of the African population. For the moment, the combination of artemether and lumefantrine (Coartem) is the only commercially available co-formulated artemisinin-containing combination therapy (ACT) for malaria. Several other Acts are in mid or late phase of development, like Ramekin, a combination of piperaquine and dihydroartemisinin. This drug, only registered in China and Cambodia, has been shown to be highly efficacious against multi-drug resistant parasites and no serious adverse drug reactions have been noted or reported. Moreover this new two-drug fixed combination antimalarial is quite inexpensive, it costs about $ 1 for an adult treatment. The proposed pilot work is a part of a PhD study, which aims to compare the clinical efficacy and safety of Artekin and Coartem to SP in children under 5 years with symptomatic malaria, and also to assess the Artekin pharmacokinetics and its in vitro activity. This study will concentrate on the evaluation of efficacy and safety of these three drugs in children under 5 years. The study will take place in the Kilombero district in the Morogoro region of southern Tanzania. The efficacy of different regimens in terms of resolution of symptoms present at baseline will be assessed. All comparisons will be made relative to SP as the standard treatment. Because of its efficacy and relatively low cost , the use of Artekin is likely to increase in the future, but more information about its efficacy in area of intense malaria transmission and its safety in children are needed. This study could be an important step in the international registration of the drug. Partners institutions: Université de Neuchâtel Institut de zoologie Rue Emile-Argand 11 CH-2007 Neuchâtel http://www.unine.ch Christian Nsanzabana +41-(0)-32-718 30 40 christian.nsanzabana@unine.ch Prof. Dr. Bruno Betschart +41-(0)-32-718 30 45 bruno.betschart@unine.ch Ifakara Health Research and Development Centre (IHRDC) Off Mlabani Passage Box 53 Ifakara, Tanzania http://www.ihrdc.org Dr. Hassan Mshinda +255232625164/ +255744 hmshinda@ifakara.mimcom.net Dr. Salim Abdulla +255744744555 / +255748744555 salim_abdulla@hotmail.com Swiss Tropical Institute Socinstrasse 57 CH-4002 Basel http://www.sti.ch Prof. Dr. Marcel Tanner +41-(0)-26- 284 82 83 marcel.tanner@unibas.ch