A Study to Assess Current Standard Malaria Treatment Guidelines in the Republic of the Sudan

A Study to Assess Current Standard Malaria Treatment Guidelines and Evaluate Recently Developed G6PD Diagnostic Tools in the Republic of the Sudan

This is a randomized controlled trial to assess the efficacy and safety of the national malaria treatment guidelines, asses the efficacy and safety of artesunate and sulphadoxine - pyrimethamine (AS+SP) for treatment in uncomplicated P. falciparum and P. vivax malaria and the hematologic effect of 14 days routine primaquine based radical cure in patients suffering from a P. vivax or mixed infection.

Inclusion Criteria:

• Age ≥ 12 months
• P. vivax or P. falciparum mono-infection or P. vivax / P. falciparum mixed infection
• Presence of axillary temperature ≥ 37.5°C or history of fever during the past 24 hrs
• Able to tolerate oral medication
• Able and willing to comply with the study protocol for the duration of the study
• Informed consent from the patient or from a parent or guardian in the case of children

Exclusion Criteria:

• Bodyweight ≤5kg
• Presence of general danger signs in children aged under 5 years or signs of severe malaria in any patient according to the definitions of WHO
• Presence of severe malnutrition
• Acute anaemia <8g/dL
• Regular medication, which may interfere with antimalarial pharmacokinetics
• History of hypersensitivity reactions or contraindications to any of the drug(s) tested or used as alternative treatment(s)
• A positive pregnancy test or lactating.