ISRCTN10364429Completed未知
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)
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)0 sites500 target enrollmentStarted: June 7, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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