A randomised open label trial to assess the efficacy, safety, and pharmacokinetic parameters of a fixed dose formulation of artesunate-mefloquine and standard dose artesunate and mefloquine as loose tablets for treatment of uncomplicated falciparum malaria (Thailand)

Not Applicable

Completed

• Conditions: Malaria; Infections and Infestations

• Registration Number: ISRCTN24192353
• Lead Sponsor: Drugs for Neglected Diseases initiative (DNDi) (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-07
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age 18 to 65 years
2. Body weight at least 40 kg
3. Microscopically confirmed, monoinfection of P. falciparum (parasitaemia more than 2/200 White Blood Cell count [WBC]). Note: if vivax parasitaemia is detected after Day 0, patients will still be kept in the study and follow the schedule of investigations.
4. History of fever or presence of fever (axillary temperature more than 37.5°C)
5. Written informed consent

Exclusion Criteria

1. Pregnant or lactating women
2. P. falciparum asexual stage parasitaemia more than 4% red blood cells (175,000/µl)
3. Clinical and/or lab features of severe malaria:
3.1. Impaired consciousness
3.2. Inability to eat and drink
3.3. Vomiting more than two episodes in preceeding 24 hours
3.4. Convulsions during present illness
3.5. Prostration
3.6. Severe anaemia (haematocrit [Hct] less than 20%)
3.7. Respiratory distress/pulmonary oedema
3.8. Shock
3.9. Spontaneous bleeding
3.10. Acute haemolysis with haemoglobinuria
3.11. Acute renal failure
3.12. Hyperbilirubinaemia (more than 3 mg/dL)
3.13. Hypoglycaemia
3.14. Acidosis
4. Baseline electrocardiogram (ECG) abnormality
5. Recent ingestion of mefloquine within previous 60 days
6. Contraindications to mefloquine
7. History of convulsions and/or psychiatric illnesses
8. Known hypersensitivity to artemisinins or mefloquine
9. Splenectomy

Study & Design

• Study Type: Interventional
• Study Design: Not specified