Study 13: Pre-referral rectal artesunate to prevent death and disability in severe malaria

Study 13, conducted between Aug 2000 and July 2006, investigated whether rectal artesunate (RAS) reduced mortality and permanent disability in patients thought to have malaria, could not be treated orally and would take several hours to access injectable treatment at a clinic. The study took place in 291 rural villages in Ghana, Tanzania, and Bangladesh, where patients were given either a rectal artesunate suppository or placebo before being referred to a clinic where the necessary treatment could be given. 

African patients were between 6-72 months and patients in Asia included all ages. 

Conclusions of study

  • Pre-referral rectal artesunate significantly reduced death or permanent disability in patients still not in clinic after more than 6 h, half of which were still not there after more than 15 h, (29/1566 [1·9%] vs 57/1519 [3·8%])

  • There was no reduction in early mortality (56 vs 51 deaths within 6 h; median 2 h)

  • In patients reaching a clinic within 6 h (median 3 h), pre-referral artesunate had no significant effect on the mortality rate or permanent disability (71/4450).

Overall, it was concluded that if patients with severe malaria cannot be treated orally and access to injections will take several hours, a single inexpensive artesunate suppository at the time of referral substantially reduces the risk of death or permanent disability.