Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Study hypothesis
Artemether/lumefantrine (Coartem®) and artesunate/amodiaquine (Coarsucam®) remain effective and well tolerated for the treatment of uncomplicated falciparum malaria in Burkina Faso.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Malaria
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Artemether/lumefantrine (Coartem®), artesunate/amodiaquine (Coarsucam®)
Primary outcome measures
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 measures
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
Overall trial start date
12/10/2009
Overall trial end date
31/01/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
197
Participant exclusion criteria
1. Severe malaria
2. Unable to comply with planned follow up
3. Pregnancy
Recruitment start date
12/10/2009
Recruitment end date
31/01/2010
Locations
Countries of recruitment
Burkina Faso
Trial participating centre
Institut de Recherche en Sciences de la Santé - Direction Régionale de l'Ouest (IRSS-DRO)
Bobo-Dioulasso
01
Burkina Faso
Funders
Funder type
Government
Funder name
National Malaria Control Programme (Burkina Faso)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary