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ARTESUNATE
MALARIA
Framework programme: 5
Project number:
QLK2-CT-2001-01430
EC contribution: € 1 104 602
Duration: 36 months
Type: RS
Starting date: 1 July 2001
Graphic element Research and Development of Rectal Artesunate
Keywords: Severe malaria; artesunate; suppository; emergency treatment

Summary:

The project finalises the development of an antimalarial in suppository formulation for emergency treatment of life-threatening malaria. The intended beneficiary is a patient living in or travelling to a malaria endemic country. The drug is to be developed to provide therapeutic cover for patients with severe disease, who can no longer take drugs by mouth, and who cannot access injectable treatment, until they reach facilities where definitive therapy can be provided.

Problem:

Survival from severe malaria depends upon speed of chemotherapy.  Patients with malaria who are not able to take fluids and medicines by mouth, and who do not have ready access to treatment by reason of the distance at which they live from a health facility, are at considerable risk of deteriorating and dying before getting to a clinic where effective treatment is available. This is how most lives are lost from acute Plasmodium falciparum infection, particularly amongst infants and children, and especially in the rural areas of sub-Saharan Africa, South East Asia and the Indian sub-continent. Therefore the development, registration and introduction of a therapy that substitutes for an injectable drug, allowing emergency treatment for patients unable to reach a hospital, has a realistic prospect of saving lives of infants, children and adults with malaria of a severity that is potentially life-threatening, and where at present no treatment  is available.

Aim:

The project aims to develop a safe and effective emergency treatment for acute life threatening malaria for patients in malaria endemic areas who cannot access injectable treatment quickly, and therefore die.

Expected results

  • Development of a high quality, efficacious antimalarial drug for use in European Union countries and the United States.
  • Critical assessment of the efficacy of the drug as given in conditions of use. Development and implementation of a safety register to monitor safety of the drug in one site.
  • A drug available for travellers who could have a very high case-fatality rate from malaria.
  • An added value to the development of oral artesunate-combination therapy for malaria to halt the spread of drug resistance.

Potential applications:

The development of a rectal formulation of artesunate, a semi-synthetic derivative of artemisinin, for substantially reducing the risk of a fatal outcome in patients (mainly infants and children) with life-threatening malaria is a primary tool for reducing the burden of malaria in malaria endemic areas. The drug will be placed on the National Essential Drugs’ list.

Coordinator:

Melba Gomes
UNDP/World Bank/WHO
Special Programme for Research and Training in Tropical Diseases
World Health Organisation
Avenue Appia 20
1211 Geneva 27
Switzerland
Tel: +41 22 791 3813
Fax: +41 22 791 4774
E-mail: GOMESM@who.int
Website: http://www.who.int/tdr/

Partners:

Principal
Scientific
Participants
Official Address Other Information
2Birna Trap, Financial CoordinatorEuro Health Group
Tinghojvej 77
DK-2860 Soborg, Copenhagen
Denmark
Tel: +45 39 696888
Fax: +45 39 695888
E-mail: BTRAP@EHG.DK
3Robert CarterKnoll Ag
Postfach 631
Oristalstrasse 65
CH–4410 Liestal
Switzerland
Tel: +41 61 921 0505
Fax: +41 61 921 2563
E-mail: robert.carter@knoll-ag.ch
4Sornchai Looareesuwan DeanFaculty of Tropical Medicine
Mahidol University
42/46 Rajvithi Road
Bangkok
Thailand
Tel: +66 2 247 1688
Fax: +66 2 647 1688
E-mail: tmslr@mahidol.ac.th
5W. BossertR P Scherer GmbH
Postfach 1243
DE-69402 Eberbach Baden
Germany
Tel: +49 6271 843325
Fax: +49 6271 843700
E-mail: werner.bossert@rpscherer.com
6John O Gyapong
Director
Health Research Unit
Ministry of Health
P O Box 184
Accra
Ghana
Tel: +233 21 230220
Fax. +233 21 226739
E-mail: John.Gyapong@hru-moh.org
7Peter FolbGroote Schuur Hospital Observatory , Department of Pharmacology
P O Box 7925
K 435 Old Main Building
Cape Town
Tel: +27 21 406 6286
Fax. +27 21 448 6181
E-mail: pfolb@uctgsh1.uct.ac.za

 
 
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