A randomised, open study to assess the safety and efficacy of a new artesunate-mefloquine coformulation with an equivalent dose regimen of the individual drugs for the treatment of acute uncomplicated falciparum malaria (Thailand)
- Conditions
- MalariaInfections and Infestations
- Registration Number
- ISRCTN10364429
- Lead Sponsor
- Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 500
1. Age more than six months, either sex
2. Minimum weight of 5 kg
3. Microscopically confirmed mono or mixed infection of P. falciparum (asexual falciparum parasitaemia more than 5/500 White Blood Cell [WBC] count)
4. History of fever or presence of fever (tympanic or axillary temperature more than 37.5°C)
5. Written informed consent to participate in trial
1. Pregnancy or lactation
2. P. falciparum asexual stage parasitaemia more than 4% red blood cells (175,000/µL)
3. Clinical features of severe malaria: impaired consciousness, inability to drink or breast feed, convulsions during the present illness, prostration, severe anaemia, respiratory distress, shock, spontaneous bleeding, acute haemolysis with haemoglobinuria
4. Other significant illnesses or signs e.g. severe jaundice, liver disease, renal disease, severe malnutrition
5. Recent ingestion of mefloquine within previous 60 days
6. Contraindications to mefloquine - history of convulsions and/or neuropsychiatric illnesses
7. Known hypersensitivity to artemisinins or mefloquine
8. Splenectomy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method