First line therapy for uncomplicated falciparum malaria with Coartem® and Coarsucam® in Burkina Faso
| ISRCTN | ISRCTN71912942 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71912942 |
| Secondary identifying numbers | N/A |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jean Bosco
Scientific
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Artemether/lumefantrine (Coartem®), artesunate/amodiaquine (Coarsucam®) |
| Primary outcome measure | 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 study start date | 12/10/2009 |
| Completion date | 31/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 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
Institut de Recherche en Sciences de la Santé - Direction Régionale de l'Ouest (IRSS-DRO)
Bobo-Dioulasso
01
Burkina Faso
01
Burkina Faso
Sponsor information
Institute of Research in Health Sciences (Institut de Recherche en Sciences de la Santé [IRSS]) (Burkina Faso)
Government
Government
Direction Régionale de l'Ouest (DRO)
399 Avenue de la Liberte
BP: 545
Bobo-Dioulasso
01
Burkina Faso
"ROR" |
https://ror.org/05m88q091 |
|---|
Funders
Funder type
Government
National Malaria Control Programme (Burkina Faso)
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 |
