Efficacy and safety of Artesunate plus Sulphadoxine-Pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria in malaria control center Asadabad in Kunar province of Afghanistan

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12612001049864
• Date of registration: 02/10/2012
• Prospective Registration: No
• Primary sponsor: Research Department, Ministry of Publich Health, Afgahnistan
• Public title: Efficacy and safety of Artesunate plus Sulphadoxine-Pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria in malaria control center Asadabad in Kunar province of Afghanistan
• Scientific title: Efficacy and safety of Artesunate plus Sulphadoxine-Pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria in malaria control center Asadabad in Kunar province of Afghanistan
• Date of first enrolment: 27/09/2012
• Target sample size: 88
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12612001049864.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Afghanistan

Contacts

• Name: Dr. Ghulam Rahim Awab

• Name: Dr. Ghulam Rahim Awab

Key inclusion & exclusion criteria

Inclusion criteria: Age above 4 months, except females aged between 12 and 17 years
Mono-infection with P. falciparum detected by microscopy
Parasitemia 500-100,000 per microliter, asexual forms
Axillary or tympanic temperature greater than 37.5 C or history of fever during the past 24 hours
Ability to swallow oral medication
Ability and willingness to follow protocol procedures and visit schedule
Informed consent from patient or from parent or legal guardian for children under 16 years
Exclusion criteria: Presence of general danger signs of severe malaria in children under 5 years
Mixed or mono-infection with another Palsmodium species
Pregnancy or breastfeeding
Presence of severe malnutrition
Presence of febrile conditions due to diseases other than malaria
Regular medication which may interfere with the antimalarial pharmacokinetics
History of hypersensitivity reactions or contraindications to any study medications.
Unable to or unwilling to take pregnancy test or contraceptives due to social-cultural reason

Age minimum: 4 Months
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

uncomplicated falciparum malaria;
uncomplicated falciparum malaria

Infection - Studies of infection and infectious agents

Intervention(s)

People with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with a combiantion of artesunate plus sulphadoxine-pyrimethamine (AS plus SP) and observed for 42 days. Artesunate tablets (100 mg) will be administered orally once a day at a dose of 4 mg/kg per day for three consecutive days. Sulphadoxine-pyrimethamine tablets (500/25 mg) will be administered orally once a day for three days. The number of tablets to be administered is based on patient age /5-11 months = half tablet; 1-6 years = 1 tablet; 7-13 years= 2 tablets; 13 years and over = 3 tablets). The dosing regimen of artesunate plus sulphadoxine-pyrimethamine correspond to the standard of care for the treatment of acute uncomplicated malaria in Afghanistan.

Primary Outcome(s)

Percent of treatment failures (early treatment failure + late clinical failure + late parasitological failure) as per latest WHO protocol on monitoring efficacy of antimalarial drug (WHO 2009)[Day 42 following initiation of treatment.]

Secondary Outcome(s)

Percent of adverse events occurring after initiation of treatment whether considered related or not to the medicinal products. Known side effects include stomach discomfort and dizziness. Other rare or unexpected adverse events may occur and include allergic reaction, vomiting, headache and body ache, and convulsions. However, some adverse eventss may be disease-related.[Day 42 following initiation of treament]

Secondary ID(s)

none

Source(s) of Monetary Support

World Health Organisation

Ethics review

Status: Approved
Approval date:
Contact:

WHO ERC