Artemisinin Combination Therapies (ACTs) efficacy for uncomplicated falciparum malaria treatment in Burkina Faso
| ISRCTN | ISRCTN90823663 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90823663 |
| Secondary identifying numbers | N/A |
- 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
Plain English Summary
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
Scientific
BP 545
Bobo Dioulasso
150000
Burkina Faso
Study information
| Study design | Randomized controlled open trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Efficacy and tolerability of artemether lumefantrine and amodiaquine artesunate for the treatment of uncomplicated falciparum malaria in Burkina Faso |
| Study hypothesis | Artemether-lumefantrine (AL) and artesunate-amodiaquine are equally effective in the treatment of malaria in Burkina Faso. |
| Ethics approval(s) | Centre Muraz Ethics Committee |
| Condition | 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 | Risk of treatment failure unadjusted and adjusted by genotyping at day 28 and tolerability |
| Secondary outcome measures | 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 |
| Overall study start date | 29/09/2011 |
| Overall study end date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 780 patients |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 29/09/2011 |
| Recruitment end date | 31/12/2012 |
Locations
Countries of recruitment
- Burkina Faso
Study participating centre
150000
Burkina Faso
Sponsor information
Government
BP 7009
Ouagadougou
01
Burkina Faso
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
21/04/2017: Plain English summary added.
