Efficacy of ArTiMist™ in Children

An Open Label Randomised Comparative Trial to Establish the Efficacy of 3 mg/kg ArTiMist™ When Compared to Intravenous Quinine in Children With Severe or Complicated Falciparum Malaria, or Uncomplicated Falciparum Malaria With Gastrointestinal Complications

The purpose of this study is to compare the efficacy of Artemether Sublingual Spray (ArTiMist™) with intravenous quinine in children with severe or complicated falciparum malaria, or children with uncomplicated malaria with gastrointestinal complications.

Inclusion Criteria:

1. The patient's parent or attendant relative has provided informed consent and the patient has assented (where relevant) to participation in the trial

2. The patient is a child that weighs between 5 and 15 kg (kilogram)

3. The patient has falciparum malaria as evidenced by

   1. Thick or thin blood smears of > 500 P falciparum per mcl (microlitre)(patients with mixed infections may be included provided >500 P Falciparum /mcl) and /or
   2. Positive RDT (rapid diagnostic test)for malaria

4. The patient has either

   1. severe or complicated malaria as determined by the Investigator based on the WHO criteria for severity, or
   2. the patient has uncomplicated malaria but is unable to tolerate oral medication as a result of gastrointestinal complications such as vomiting or diarrhoea.

Exclusion Criteria:

1. Attending relative or parent does not provide informed consent for participation, or the child if capable does not assent to participation in the trial.
2. Ability to tolerate oral therapy
3. Patient has received any treatment with an artemisinin or quinine in the last 24 hours
4. Patient has evidence of significant co-infections (this does not include mixed Plasmodium infections).
5. Patient is allergic or intolerant to artemisinins.