Title
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
Phase
Phase 2Lead Sponsor
Proto Pharma LtdStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Falciparum MalariaStudy Participants
31The 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.
20 mg/kg intravenous quinine loading dose, followed by 10 mg/kg intravenously every 8 hours until resumption of normal oral therapy
Artemether sublingual spray 3 mg/kg at protocol specified timepoints until resumption of normal oral therapy
Inclusion Criteria: The patient's parent or attendant relative has provided informed consent and the patient has assented (where relevant) to participation in the trial The patient is a child that weighs between 5 and 15 kg (kilogram) The patient has falciparum malaria as evidenced by 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 Positive RDT (rapid diagnostic test)for malaria The patient has either severe or complicated malaria as determined by the Investigator based on the WHO criteria for severity, or 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: Attending relative or parent does not provide informed consent for participation, or the child if capable does not assent to participation in the trial. Ability to tolerate oral therapy Patient has received any treatment with an artemisinin or quinine in the last 24 hours Patient has evidence of significant co-infections (this does not include mixed Plasmodium infections). Patient is allergic or intolerant to artemisinins.
| Event Type | Organ System | Event Term | ArTiMist | Intravenous Quinine |
|---|
The time taken for the parasite count to fall 90% from baseline
The time taken for the parasite count to fall 50% from baseline
Time in hours from the initiation of therapy until the first of two successive parasite-negative smears were obtained
Reduction in parasitaemia from baseline at 24 h after the first dose of study medication
Reduction in parasitaemia from baseline at 12 hours after the first dose of study medication
