|
ISRCTN
|
ISRCTN90823663
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Artemisinin Combination Therapies (ACTs) efficacy for uncomplicated falciparum malaria treatment in Burkina Faso
|
|
Scientific title
|
Efficacy and tolerability of artemether lumefantrine and amodiaquine artesunate for the treatment of uncomplicated falciparum malaria in Burkina Faso
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
Artemether-lumefantrine (AL) and artesunate-amodiaquine are equally effective in the treatment of malaria in Burkina Faso.
|
|
Lay summary
|
Lay summary under review 4
|
|
Ethics approval
|
Centre Muraz Ethics Committee
|
|
Study design
|
Randomized controlled open trial
|
|
Countries of recruitment
|
Burkina Faso
|
|
Disease/condition/study domain
|
Malaria
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
29/09/2011
|
|
Anticipated end date
|
31/12/2012
|
|
Status of trial
|
Ongoing |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
780 patients
|
|
Interventions
|
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
|
|
Primary outcome measure(s)
|
Risk of treatment failure unadjusted and adjusted by genotyping at day 28 and tolerability
|
|
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
|
|
Sources of funding
|
1. Ministry of Health (Burkina Faso)
2. National Malaria Control Program (Burkina Faso)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Prof
Jean Bosco
Ouedraogo
|
|
Address
|
BP 545
|
|
City/town
|
Bobo Dioulasso
|
|
Zip/Postcode
|
150000
|
|
Country
|
Burkina Faso
|
|
Sponsor
|
National Malaria Control Program (Burkina Faso)
|
|
Address
|
BP 7009
|
|
City/town
|
Ouagadougou
|
|
Zip/Postcode
|
01
|
|
Country
|
Burkina Faso
|
|
Date applied
|
29/09/2011
|
|
Last edited
|
30/01/2012
|
|
Date ISRCTN assigned
|
30/01/2012
|
