NCT01258049

A Phase III, Randomised, Open Labelled, Active Controlled, Multi Centre, Superiority Trial of ArTiMist™ Versus Intravenous Quinine in Children With Severe or Complicated Falciparum Malaria, or Uncomplicated Falciparum Malaria With Gastrointestinal Complications.

Completed Phase 3 Results posted Last updated 27 January 2014

What this trial tests

Phase 3 trial testing Artemether Sublingual Spray in Plasmodium Falciparum Malaria in 151 participants. Completed in 1 September 2012.

Timeline

1 December 2010

Primary endpoint
1 August 2012

1 September 2012

Quick facts

Lead sponsor	Proto Pharma Ltd
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	151
Start date	1 December 2010
Primary completion	1 August 2012
Estimated completion	1 September 2012
Sites	3 locations across Burkina Faso, Ghana, Rwanda

Drugs / interventions tested

• Artemether Sublingual Spray — full drug profile →
• Quinine (QUININE) — full drug profile →

Conditions studied

• Plasmodium Falciparum Malaria — all drugs for Plasmodium Falciparum Malaria →

Sponsor

Proto Pharma Ltd — full company profile →

Who can join

Eligibility, any sex, with Plasmodium Falciparum Malaria. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Parasitological Success (MITT)
  Time frame: 24 hours after start of treatment
  Parasitological success defined as a reduction in parasite count of ≥ 90% of baseline at 24 hours after the first dose
• Parasitological Success (PP)
  Time frame: 24 hours after start of treatment
  Parasitological success defined as a reduction in parasite count of ≥ 90% of baseline at 24 hours after the first dose

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The global pipeline of new medicines for the control and elimination of malaria.
   Anthony MP, Burrows JN, Duparc S, Moehrle JJ, et al · · 2012 · cited 100× · PMID 22958514 · DOI 10.1186/1475-2875-11-316
2. Efficacy of a novel sublingual spray formulation of artemether in African children with Plasmodium falciparum malaria.
   Bendel D, Rulisa S, Ansah P, Sirima S. · · 2015 · cited 2× · PMID 26303805 · DOI 10.1128/aac.00243-15