First line therapy for uncomplicated falciparum malaria with Coartem® and Coarsucam® in Burkina Faso
| ISRCTN | ISRCTN71912942 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71912942 |
| Protocol serial number | N/A |
| Sponsor | Institute of Research in Health Sciences (Institut de Recherche en Sciences de la Santé [IRSS]) (Burkina Faso) |
| Funder | National Malaria Control Programme (Burkina Faso) |
- Submission date
- 09/10/2009
- Registration date
- 28/06/2010
- Last edited
- 28/06/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Institut de Recherche en Sciences de la Santé - Direction Régionale de l'Ouest (IRSS-DRO)
399 Avenue de la Liberte
BP: 545
Bobo-Dioulasso
01
Burkina Faso
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | Artemether/lumefantrine (Coartem®) and artesunate/amodiaquine (Coarsucam®) remain effective and well tolerated for the treatment of uncomplicated falciparum malaria in Burkina Faso. |
| Ethics approval(s) | Ethics Committee of the Muraz Centre (Comite d'Ethique Institutionnelle du Centre Muraz), approval pending as of 09/10/2009 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Artemether/lumefantrine (Coartem®), artesunate/amodiaquine (Coarsucam®) |
| Primary outcome measure(s) |
The following will be assessed at 28 days: |
| Key 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 |
| Completion date | 31/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 197 |
| Key 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 |
| Key exclusion criteria | 1. Severe malaria 2. Unable to comply with planned follow up 3. Pregnancy |
| Date of first enrolment | 12/10/2009 |
| Date of final enrolment | 31/01/2010 |
Locations
Countries of recruitment
- Burkina Faso
Study participating centre
01
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 |