Efficacy of ArTiMist™ in Children

Summary

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.

Timeline

Start

2009-12

Primary completion

2010-01

Completion

2010-01

Outcome

Missed primary endpoint

registry ArTiMist vs Intravenous Quinine; p = 0.17; difference between treatments 26.7 (95% CI -0.3 to 53.7); Fisher Exact NCT01047436 ↗

registry ArTiMist vs Intravenous Quinine; p = 0.70; Hazard Ratio (HR) 1.05 (95% CI 0.48 to 3.01); Log Rank NCT01047436 ↗

registry ArTiMist vs Intravenous Quinine; p = 0.76; Hazard Ratio (HR) 0.92 (95% CI 0.34 to 2.18); Log Rank NCT01047436 ↗

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