Efficacy and safety of Artesunate plus Sulfadoxine /Pyrimethamine and Artemether-Lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kassala (Kassala State), Kosti (White Nile State), Sinnar (Sinnar State), Damazin (Blue Nile State), and Gadaref (Gadaraf State), Suda

Not Applicable

• Conditions: uncomplicated falciparum malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12613000945729
• Lead Sponsor: Republic of Sudan Federal Ministry of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 704

Inclusion Criteria

Age above six months excluding female minors aged 12-17 years inclusive and unmarried women above 17 years;
Mono-infection with P. falciparum detected by microscopy;
Parasitaemia of 1000-100,00 per microlieter asexual forms;
Presence of axillary temperature equal or greater 37.5 degrees Celsius, or history of fever during the past 24 h;
Ability to swallow oral medication;
Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
Informed consent from the patient or from a parent or guardian in the case of children.

Exclusion Criteria

Presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO;
Mixed or mono-infection with another Plasmodium species detected by microscopy;
Presence of severe malnutrition (defined as a child whose growth standard is below –3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference less than 110 mm);
Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
Regular medication, which may interfere with antimalarial pharmacokinetics;
History of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatments; and
A positive pregnancy test or breastfeeding.

Study & Design

• Study Type: Observational
• Study Design: Not specified