Superiority of ArTiMist Versus Quinine in Children With Severe Malaria

Summary

The purpose of this study is to demonstrate that ArTiMist (sublingual artemether spray) is better than intravenous quinine in reducing parasite counts by \>= 90% within 24 hours after the start of treatment in children with severe malaria, or uncomplicated malaria with gastrointestinal complications

Timeline

Start

2010-12

Primary completion

2012-08

Completion

2012-09

Outcome

Met primary endpoint

registry analysis (superiority or other test); ArTiMist vs Quinine; p <0.005; Percentage Difference 54.85 (95% CI 42.25 to 67.45); Regression, Logistic NCT01258049 ↗

registry analysis (superiority or other test); ArTiMist vs Quinine; p <0.005; Percentage Difference 55.01 (95% CI 42.44 to 67.58); Regression, Linear NCT01258049 ↗

Publications

• Bendel D, Rulisa S, Ansah P, Sirima S. Efficacy of a novel sublingual spray formulation of artemether in African children with Plasmodium falciparum malaria. Antimicrob Agents Chemother. 2015 Nov;59(11):6930-8. doi: 10.1128/AAC.00243-15. Epub 2015 Aug 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Artemether	Small molecule	3 mg/kg	Other
Comparator	Quinine	Small molecule	10 mg/kg	Intravenous

Indications