Status:
COMPLETED
Superiority of ArTiMist Versus Quinine in Children With Severe Malaria
Lead Sponsor:
Proto Pharma Ltd
Conditions:
Plasmodium Falciparum Malaria
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 tre...
Detailed Description
Malaria causes significant morbidity and mortality in children in developing countries, despite the availability of highly effective antimalarial therapy. One of the key contributing factors is the de...
Eligibility Criteria
Inclusion
- The patient's legally acceptable representative has provided informed consent and the patient has assented (where relevant) to participation in the trial
- The patient is a child that weighs between 5.00 kg and 15.00 kg inclusive
- 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)
- 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
- 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.
- Ability to tolerate oral therapy
- Patient has received any antimalarial therapy within the 7 days prior to first study drug administration.
- Patient has evidence of significant co-infections (this does not include mixed Plasmodium infections).
- Patient has a contraindication, allergy or is otherwise intolerant to either artemether or quinine .
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT01258049
Start Date
December 1 2010
End Date
September 1 2012
Last Update
February 28 2014
Active Locations (3)
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1
Centre National de Recherche et de Formation sur le Paludisme (CNRFP)
Ouagadougou, Burkina Faso, 01 BP 2208
2
Navrongo Health Research Centre
Navrongo, Navrongo, Ghana, P.O. Box 114
3
Rwinkwavu District Hospital
Rwinkwavu, Eastern Province, Rwanda