Superiority of ArTiMist Versus Quinine in Children With Severe Malaria

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Proto Pharma Ltd
• Treatments: Artemether; Quinine

Criteria

Inclusion Criteria:

1. The patient's legally acceptable representative 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 5.00 kg and 15.00 kg inclusive

3. The patient has falciparum malaria as evidenced by thick or thin blood smears of ≥ 500 P Falciparum per mcl (patients with mixed infections may be included provided ≥ 500 P Falciparum per mcl)

4. The patient has either:

• severe or complicated falciparum malaria as determined by the investigator based on the WHO criteria for severity, and/or

• uncomplicated falciparum malaria but is unable to tolerate oral medication as a result of gastrointestinal complications such as vomiting or diarrhoea.

Exclusion Criteria:

1. The patient's legally acceptable representative 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 antimalarial therapy within the 7 days prior to first study drug administration.

4. Patient has evidence of significant co-infections (this does not include mixed Plasmodium infections).

5. Patient has a contraindication, allergy or is otherwise intolerant to either artemether or quinine .