Effective and safe treatment for malaria in pregnancy in India: a randomised controlled trial.
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.
Daniel Chandramohan MBBS MSc PhD
Current Appointment: Professor of Public Health at LSHTM
Professor Chandramohan is a clinical epidemiologist and graduated in medicine in 1975. He then worked as a primary care physician in India and Ethiopia followed by a period working in one of OXFAM's primary care projects in Zimbabwe that aimed to address the inequity in health care and health through comprehensive primary care and then became a district medical officer in Zimbabwe.
His research career started as a research fellow at the London School of Hygiene and Tropical Medicine (LSHTM) in 1992. In 1996, he joined the malaria knowledge programme of the LSHTM funded by the UK DFID and started to work on diagnosis, treatment and chemoprevention of malaria.
His main research interest ranges from diagnosis, treatment and chemoprevention of malaria to drug resistance, micronutrients and surveillance.
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)