Artemisinin Combination Therapies (ACTs) efficacy for uncomplicated falciparum malaria treatment in Burkina Faso

ISRCTN	ISRCTN90823663
DOI	https://doi.org/10.1186/ISRCTN90823663
Protocol serial number	N/A
Sponsor	National Malaria Control Program (Burkina Faso)
Funders	Ministry of Health (Burkina Faso), National Malaria Control Program (Burkina Faso)

Submission date: 29/09/2011
Registration date: 30/01/2012
Last edited: 21/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Malaria is a serious tropical disease spread by mosquitoes. It can be prevented and treated with antimalarial drugs. The aim of this study is to assess the effectiveness and side effects of the antimalarial drug combinations artemether-lumefantrine and amodiaquine-artesunate for the treatment of malaria in Burkina Faso.

Who can participate?
Patients aged over 6 months with malaria

What does the study involve?
Participants are randomly allocated to be treated with either artemether-lumefantrine or artesunate-amodiaquine. Participants who fail to respond to initial treatment are given quinine, the standard treatment for malaria in Burkina Faso. Participants are followed up for 42 days and are asked to return for assessment on days 1, 2, 3, 7, 14, 21, 28 and any unscheduled day that they feel ill.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
The study is conducted at public health facilities in Sarfalao, Dori and Gaoua (Burkina Faso)

When is the study starting and how long is it expected to run for?
September 2011 to December 2012

Who is funding the study?
1. Ministry of Health (Burkina Faso)
2. National Malaria Control Program (Burkina Faso)

Who is the main contact?
Prof. Jean Bosco Ouedraogo

Contact information

Prof Jean Bosco Ouedraogo
Scientific

BP 545
Bobo Dioulasso
150000
Burkina Faso

Study information

Primary study design	Interventional
Study design	Randomized controlled open trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Efficacy and tolerability of artemether lumefantrine and amodiaquine artesunate for the treatment of uncomplicated falciparum malaria in Burkina Faso
Study objectives	Artemether-lumefantrine (AL) and artesunate-amodiaquine are equally effective in the treatment of malaria in Burkina Faso.
Ethics approval(s)	Centre Muraz Ethics Committee
Health condition(s) or problem(s) studied	Malaria
Intervention	Subjects will be randomized to receive either artemether-lumefantrine (AL) or artesunate-amodiaquine (ASAQ). Subjects who fail initial therapy will receive quinine which is the standard treatment for recurrent malaria in Burkina Faso. Subjects will be followed for 42 days and will be asked to return for follow-up
Intervention type	Other
Primary outcome measure(s)	Risk of treatment failure unadjusted and adjusted by genotyping at day 28 and tolerability
Key secondary outcome measure(s)	1. Prevalence of fever on days 1-3 2. Prevalence of parasitemia on days 2 and 3 3. Change in mean hemoglobin level between days 0 and 28 (or day of treatment failure) 4. Prevalence of gametocytes during follow-up 5. Risk of serious adverse events during follow-up 6. Risk of adverse events of moderate or greater severity, at least possibly related to the study medications, excluding patients requiring quinine therapy 7. Selection of molecular markers associated with drug resistance
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	780
Key inclusion criteria	1. Age > 6 months 2. Weight > 5 kg 3. Fever (> 37.5ºC axillary) or history of fever in the previous 24 hours 4. Absence of any history of serious side effects to study medications 5. No evidence of a concomitant febrile illness 6. Provision of informed consent and agreement to follow-up for 28 days 7. No evidence of severe malaria or danger signs 8. Absence of repeated vomiting of study medications on day 0 9. P. falciparum mono-infection 10. Parasite density > 2000/ul and < 200,000/ul
Key exclusion criteria	1. Severe malaria 2. Unable to respect the follow-up schedule 3. Known allergy to the study medication 4. Other chronic disease requiring care
Date of first enrolment	29/09/2011
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Burkina Faso

Study participating centre

BP 545

Bobo Dioulasso
150000
Burkina Faso

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/04/2017: Plain English summary added.