World Malaria Day 2013: malaria in pregnancy studies and future research capacity

Published on 25 April 2013

Since 2007, joint malaria prevention, control and interventions have saved many lives, but the burden of disease remains significant, especially among high risk populations including young children and pregnant women. The vast majority of estimated cases (80%) and deaths (91%) occur in sub-Saharan Africa and the vast majority of deaths (86%) occur in children under 5 years of age*. The theme of the World Malaria Day 2013, ‘Invest in the future: defeat malaria’ draws attention to the current situation and the global investment needed to sustain the gains and defeat malaria. The European and Developing Countries Clinical Trials Partnership (EDCTP) funds clinical research to accelerate the development of new or improved drugs and vaccines. As of 31 December 2012, malaria research received €49.39 million or 24.2% of EDCTP grant funds for a total of 41 grants in this field.

Malaria in pregnancy
This year EDCTP wishes to highlight research which addresses the grave problem of malaria in pregnancy. In areas where malaria is endemic, pregnant women are at high risk of increased morbidity and mortality. Malaria infection in pregnancy is associated with increased risk of anaemia in the mother and low birth weight for the baby, which is a major determinant of infant mortality. EDCTP funds several studies focusing on malaria in pregnant women. These studies are also a major component of the research conducted by the global Malaria in Pregnancy Consortium. These closely-linked projects aim to evaluate the safety and effectiveness of a new generation of antimalarial drugs both for the effective prevention and treatment of malaria in pregnancy in Africa.

PREGACT: Antimalarial treatment for African pregnant women
The PREGACT study is coordinated by Professor Umberto D’Alessandro, Institute for Tropical Medicine, Antwerp, Belgium. It aims to determine the safety and efficacy of four artemisinin-based combination treatments (dihydroartemisinin-piperaquine, mefloquine-artesunate, amodiaquine-artesunate and artemether-lumefantrine) when administered to pregnant women with P. falciparum infection during the second and the third trimester. The objective of this head-to-head comparison of the four treatments is to identify at least two valid first-line treatments and one second-line treatment.

In 2012, recruitment was completed in three of the four recruiting sites, i.e. Malawi, Zambia and Burkina Faso. The trial has recruited more than 90% of the planned sample size. There are also four ongoing PhD studies based on the scientific activities of PREGACT. The PREGACT study group comprises six African institutions in Burkina Faso (Centre Muraz, Bobo-Dioulasso), Ghana (Kwame Nkruma University of Science and Technology, Kumasi), Malawi (University of Malawi College of Medicine, Blantyre), Rwanda (Central University Hospital of Kigali), Tanzania (National Institute for Medical Research, Morogoro) and Zambia (Tropical Diseases Research Centre, Ndola). The group also comprises four European institutions in Austria (Vienna School of Clinical Research), Belgium (Institute of Tropical Medicine, Antwerp), Netherlands (Institute of Tropical Medicine and Academic Medical Centre, Amsterdam) and the United Kingdom (Liverpool School of Tropical Medicine).

MiPPAD-1 malaria trial
The Malaria in Pregnancy Preventive Alternative Drugs (MiPPAD) study is led by Prof. Clara Menéndez (Barcelona Centre for International Health Research, Spain). The objective of the study is to evaluate the safety, tolerability and efficacy of an alternative drug for preventive treatment of malaria in pregnant women. The project enrolled a total of 4,734 pregnant women in 2012, after screening 17,947 women in Benin (Allada, Sékou and Attogon), Gabon (Fougamou and Lambaréné), Mozambique (Manhiça and Maragra), and in Tanzania (Makole and Chambwino).

Several institutions support the MiPPAD project: the Barcelona Centre for International Health Research (Barcelona, Spain); the Université d'Abomey-Calavi (Cotonou, Benin); the Albert Schweitzer Hospital (Lambaréné, Gabon); the Manhiça Health Research Centre (Manhiça, Mozambique); the Ifakara Health Institute (Dodoma, Tanzania); the Kenya Medical Research Institute / Centers for Disease Control and Prevention (Nairobi, Kenya); the Vienna School of Clinical Research (Vienna, Austria); the Institut de Recherche pour le Développement (Paris, France); and the Institute of Tropical Medicine and University of Tübingen (Tübingen, Germany).

IPTp-SP: alternatives for standard intermittent preventive treatment in pregnancy
Professor Feiko ter Kuile, Liverpool School of Tropical Medicine, United Kingdom coordinates a project which investigates declining effectiveness of Intermittent Preventive Treatment in pregnancy (IPTp) and studies alternative approaches to IPTp with sulphadoxine-pyrimethamine (SP). The two options considered are replacing SP with other drugs for IPTp, and alternative strategies to replace IPTp.

The alternative approach tested is characterised by the concept of Intermittent Screening and Treatment in pregnancy ISTp. Scheduled screening for malaria is provided using a rapid diagnostic test (RDT) while RDT-positive women are then treated with a long acting ACT to clear existing infections and provide additional post-treatment prophylaxis for three to six weeks.

The research aims to evaluate the efficacy of ISTp followed by treatment of RDT-positive women with either dihydroartemisininpiperaquine (ISTp-DP) or Artemether-lumefantrine (ISTp-AL) as compared to IPTp with sulphadoxine-pyrimethamine (IPTp-SP) in the second and third trimesters. The comparison is on adverse birth outcome and malaria infection at term among HIV-negative women protected by insecticide–treated bed nets. A sub-study explores the relationship between the level of SP resistance in the population of pregnant women and the effectiveness of IPTp-SP in reducing adverse effects of malaria at birth.

This project includes five African institutions in Burkina Faso (Université de Ouagadougou), Ghana (Navrongo Health Research Centre), Malawi (University of Malawi College of Medicine), Mali (Medical Research and Training Centre), The Gambia and four European partners in Austria, Denmark (University of Copenhagen), and the United Kingdom (Liverpool School of Tropical Medicine, London School of Hygiene and Tropical Medicine), as well as one in Australia (University of Melbourne), and one in the United States of America (Centres for Disease Control and Prevention).

Training researchers and Networks of Excellence
The studies mentioned above are conducted in Africa bringing together African and European researchers in a collaborative effort. EDCTP places great value on capacity building for the conduct of clinical trials in sub-Saharan Africa. It is necessary to invest in the future of health research by supporting the development of a cadre of African researchers. As of end of 2012, EDCTP supported the training of 420 researchers at various levels of experience: Senior Fellows, Career Development Fellows and postdocs (87); PhD and MD students (144); and Master (183) and Bachelor of Science students (6).

EDCTP has also provided support to set up four regional networks of institutions which collaborate to further build capacity in their respective regions. These Networks of Excellence offer a platform for future clinical research and may contribute to greater alignment of African-European collaborative research programmes with African health research priorities as well as to greater financial support from African national governments.

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