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

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menzies School of Health Research
• Collaborator: University of Khartoum
• Treatments: Artesunate; Primaquine; Pyrimethamine; Sulfadoxine

Criteria

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.