New Drugs for IPTp
Title: Evaluation of alternative antimalarial drugs to sulfadoxine-pyrimethamine for intermittent preventive treatment in pregnancy (IPTp) in the context of insecticide treated nets
Project Coordinator(s): Clara Menendez (Spain) and Meghna Desai (USA)
European partners: Michel Cot (France), Michael Ramharter (Austria) and Gabriela Schreyer (Austria)
Site PIs: Eusebio Macete (Mozambique), Achille Massougbodji (Benin), Ghyslain Mombo-Ngoma (Gabon), Salim Abdulla (Tanzania) and Meghna Desai (Kenya)
The project aims to contribute to the development of new clinical interventions to fight malaria by evaluation of different anti-malaria drug alternatives as intermittent preventive treatment in pregnancy (IPTp) in the context of insecticide treated nets (ITNs).
The overall goal of the project is not only to develop new anti-malaria in pregnancy prevention but also to promote European and African research collaboration and strengthening the capacity of African institutions to conduct clinical research.
To evaluate new anti-malaria preventions, two clinical trials are being conducted in five African settings.
The first trial compares the safety, tolerability and efficacy of mefloquine to sulfadoxine-pyrimethamine as IPTp for the prevention for malaria in pregnancy in the context of ITNs. This study involves 4716 pregnant women in research centres in Mozambique, Benin, Tanzania and Gabon.
The second trial will determine safety and efficacy of IPTp with mefloquine among HIV infected pregnant women receiving cotrimoxazole (CTX) prophylaxis and involves 1070 women in Kenya, Tanzania and Mozambique.
During the clinical trials the investigators and study teams in African sites are gaining experience and expertise in new techniques and procedures through infrastructure and technology upgrades. Also, training is provided for staff at all levels in topics such as epidemiology, biostatistics, trial and data management, GCP/GCLP and ethics. In addition, postgraduate level training is being provided for African research staff.
The allocation of funds in this project represents a unique opportunity not only for research activities through clinical trials but the overall project objectives facilitate excellent capacity building and networking activities among all institutions involved.