Project Title: Effective and safe treatment for malaria in pregnancy in India: a randomised controlled trial.
Principal Investigators: Dr Neena Valecha (India) and Prof Daniel Chandramohan (UK)
Co-Principal investigators: Dr Anupkumar Anvikar (India) and Prof Feiko ter Kuile (UK)
Dr GPS Dhillon (Delhi, India), Dr B Shahi (Delhi, India), Dr MK Das (Ranchi, India), Dr RP Ram (Ranchi, India), Dr R Mohanty (Jamshedpur, India), Dr SK Sharma (Rourkela, India), Dr SK Mishra (Rourkela, India), Dr V Udhayakumar (USA), Prof F Nosten (Thailand), Ms J Bruce, Ms J Webster (UK), Prof B Greenwood (UK)
Study sites: Ranchi, Jamshedpur, and Rourkela
The primary objective of this trial is to assesses the efficacy of artesunate-mefloquine (AS+MQ) compared to artesunate-sulphadoxine-pyrimethamine (AS+SP) for treatment of falciparum malaria in pregnancy in India.
The secondary objectives are to assess the safety and tolerability of AS+MQ and AS+SP
The first line drug for treatment of malaria in India is AS+SP. However there have been no clinical trials of AS+SP in pregnant women in India. Furthermore malaria parasite resistance to SP has been reported from some parts of India and therefore more data on efficacy and safety of potential drug combinations for treatment of malaria in pregnancy is needed urgently.
This randomised open-label active-controlled clinical trial will involve 500 pregnant women of all parities in second and third trimesters having P falciparum parasitaemia mono infection.
This trial started in June 2010 and is expected to be completed by May 2013.
The study will provide information to the national malaria control programme to develop evidence based policy for the treatment of malaria in pregnancy in India.