Effective and safe treatment for malaria in pregnancy in India: a randomised controlled trial.
Project Coordinators: Dr Neena Valecha (India) and Prof Daniel Chandramohan (UK)
Co-Principal investigators: Dr Anupkumar Anvikar (India) and Prof Feiko ter Kuile (UK)Project Partners:
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)
The primary objective of this trial was to assess the efficacy of artesunate-mefloquine (AS+MQ) compared to artesunate-sulphadoxine-pyrimethamine (AS+SP) for treatment of falciparum malaria in pregnancy in India, with a secondary objective 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 and resistance to SP by the malaria parasite 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 was required. This randomised open-label active-controlled clinical trial involved 247 pregnant women in second and third trimesters having P falciparum parasitaemia mono infection.
The cure rates by day 63 were 95.2% and 95.1% respectively, and 100% in the per protocol population in both arms, with no significant differences in tolerability. The publication of the main findings of the trial and cohort are in preparation and will be provided to the national malaria control programme to develop evidence based policy for the treatment of malaria in pregnancy in India.