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), Sudan

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12613000945729
• Date of registration: 27/08/2013
• Prospective Registration: Yes
• Primary sponsor: Republic of Sudan Federal Ministry of Health
• Public title: 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), Sudan
• Scientific title: Assessment of the therapeutic efficacy, in terms of proportion of patients with PCR-corrected adequate clinical and parasitological response of the combination of artesunate plus sulfadoxine-pyrimethamine and that of the fixed combination of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in patients over 6 months of age recruited from Kassala, Kosti, Sinnar, Damazin, and Gadaref, Sudan
• Date of first enrolment: 09/09/2013
• Target sample size: 704
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12613000945729.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Sudan

Contacts

• Name: Dr Khalid Elmardi

• Name: Dr Khalid Elmardi

Key inclusion & exclusion criteria

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.


Age minimum: 6 Months
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Infection - Other infectious diseases

uncomplicated falciparum malaria;
uncomplicated falciparum malaria

Intervention(s)

This surveillance study is a one arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated falciparum malaria. In five study sites eligible patients will be treated with artesunate at a dose of 4 mg per kg plus a fixed combination of sulfadoxine at a dose of 25 mg per kg and pyrimethamine at a dose of 1.25 mg per kg on the first day, then 4 mg per kg ofartesunate on the two following days. Patients will receive tablets containing 50 mg of artesunate and tablet containing 500 mg of sulfadoxine plus 25 mg of pyrimethamine. The number of tablets to be administered is determined according to body weight. In three other sites eligible patients will be administered fixed combination tablet, each containing 20 mg of artemether and 120 mg of lumefantrine, twice a day for three consecutive days. The number of tablets to be administered twice daily 8 hours apart is determined according to body weight: 5-14 kg, 1 tab; 15-24 kg, 2 tab; 25- 34 kg 3 tab; over 35kg 4 tab. Patients will be seen for clinical and parasitological evaluation, daily for the first 3 days, then weekly until day 28, or at any time if malaria syptoms re-occurred.

Primary Outcome(s)

Proportion of patients with adequate clinical and parasitological response adjusted by polymerase chain reaction (PCR)[Day 28]

Secondary Outcome(s)

Nature and incidence of adverse events. Possible adverse events are those known to occur with antimalarials, and include headache, body ache, nausea, vomiting, abdominal discomfort, liver enzyme elevation, and dizziness.[Day 28]

Secondary ID(s)

None

Source(s) of Monetary Support

Republic of Sudan Federal Ministry of Health

World Health Organisation

Ethics review

Status: Approved
Approval date:
Contact:

World Health Organisation Ethics Review Committee