|
ISRCTN
|
ISRCTN71912942
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
First line therapy for uncomplicated falciparum malaria with Coartem® and Coarsucam® in Burkina Faso
|
|
Scientific title
|
Assessment of first line therapy for uncomplicated falciparum malaria with artemether/lumefantrine (Coartem®) and artesunate/amodiaquine (Coarsucam®) in Bobo-Dioulasso, Burkina Faso: a randomised controlled trial
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
Artemether/lumefantrine (Coartem®) and artesunate/amodiaquine (Coarsucam®) remain effective and well tolerated for the treatment of uncomplicated falciparum malaria in Burkina Faso.
|
|
Lay summary
|
|
|
Ethics approval
|
Ethics Committee of the Muraz Centre (Comite d'Ethique Institutionnelle du Centre Muraz), approval pending as of 09/10/2009
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Burkina Faso
|
|
Disease/condition/study domain
|
Malaria
|
|
Participants - inclusion criteria
|
1. Not previously enrolled in this study
2. Both males and females, aged greater than 6 months
3. Weight greater than 5 kg
4. Fever (greater than 37.5ºC axillary) or history of fever in the previous 24 hours
5. Absence of any history of serious side effects to study medications
6. No evidence of a concomitant febrile illness in addition to malaria
7. Provision of informed consent and ability to participate in 28-day follow-up (patient has easy access to health unit)
8. No danger signs or evidence of severe malaria defined as:
8.1. Unarousable coma (if after convulsion, greater than 30 minutes)
8.2. Repeated convulsions (greater than two within 24 hours)
8.3. Recent convulsions (one to two within 24 hours)
8.4. Altered consciousness (confusion, delirium, psychosis, coma)
8.5. Lethargy
8.6. Unable to drink or breast feed
8.7. Vomiting everything
8.8. Unable to stand/sit due to weakness
8.9. Severe anaemia (Hb less than 5.0 g/dL)
8.10. Respiratory distress (laboured breathing at rest)
8.11. Jaundice
9. Plasmodium falciparum mono-infection
10. Parasite density greater than 2,000/ul and less than 200,000/ul
|
|
Participants - exclusion criteria
|
1. Severe malaria
2. Unable to comply with planned follow up
3. Pregnancy
|
|
Anticipated start date
|
12/10/2009
|
|
Anticipated end date
|
31/01/2010
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
197
|
|
Interventions
|
Artemether/lumefantrine (Coartem®) versus artesunate/amodiaquine (Coarsucam®). The drugs will be administrated over three days orally. The dose will be calculated based on the child's weight.
|
|
Primary outcome measure(s)
|
The following will be assessed at 28 days:
1. Risk of recurrent malaria
2. Risk of recurrent parasitaemia
3. Risk of clinical treatment failure
4. Risk of parasitological treatment failure
|
|
Secondary outcome measure(s)
|
1. Prevalence of fever (defined as both subjective fever in the previous 24 hours and measured axillary temperature greater than 37.5°C) on follow-up days 1, 2, and 3
2. Prevalence of parasitaemia on follow-up days 2 and 3
3. Change in mean haemoglobin from day 0 to 28 (or day of rescue therapy for patients classified as late clinical failure [LCF] or late parasitological failure [LPF])
4. Prevalence of gametocytaemia and gametocyte density on follow-up days 2, 3, 7, 14, 21, 28
5. Risk of serious adverse events: proportion of patients experiencing any serious adverse event in each treatment group during the 28-day follow-up period (both including and excluding patients classified as early treatment failure [ETF] or LCF, as recurrent malaria can be confounding)
6. Risk of adverse events of moderate or greater severity, at least possibly related to the study medications (both including and excluding patients classified as ETF or LCF)
7. Change in the prevalence of molecular markers associated with drug resistance from day 0 to the day of recurrent parasitaemia
|
|
Sources of funding
|
National Malaria Control Programme (Burkina Faso)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Prof
Jean
Bosco
|
|
Address
|
Institut de Recherche en Sciences de la Santé - Direction Régionale de l'Ouest (IRSS-DRO)
399 Avenue de la Liberte
BP: 545
|
|
City/town
|
Bobo-Dioulasso
|
|
Zip/Postcode
|
01
|
|
Country
|
Burkina Faso
|
|
Sponsor
|
Institute of Research in Health Sciences (Institut de Recherche en Sciences de la Santé [IRSS]) (Burkina Faso)
|
|
Address
|
Direction Régionale de l'Ouest (DRO)
399 Avenue de la Liberte
BP: 545
|
|
City/town
|
Bobo-Dioulasso
|
|
Zip/Postcode
|
01
|
|
Country
|
Burkina Faso
|
|
Date applied
|
09/10/2009
|
|
Last edited
|
28/06/2010
|
|
Date ISRCTN assigned
|
28/06/2010
|
