Treatment of uncomplicated falciparum malaria in Bobo-Dioulasso, Burkina Faso: comparison of amodiaquine sulfadoxine-pyrimethamine with Coartem
| ISRCTN | ISRCTN54261005 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54261005 |
| Secondary identifying numbers | N/A |
- Submission date
- 24/03/2006
- Registration date
- 05/05/2006
- Last edited
- 16/02/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ouedraogo Jean Bosco
Scientific
Scientific
399 Avenue de la Liberte
P O Box 545
Bobo-Dioulasso
01
Burkina Faso
| Phone | +226 20981880 |
|---|---|
| jbouedraogo.irss@fasonet.bf |
Study information
| Study design | Randomized, single-blinded, controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The efficacy of amodiaquine sulfadoxine pyrimethamine and artemether lumefantrine for the treatment of uncomplicated falciparum malaria in Bobo-Dioulasso, Burkina Faso will be equivalent |
| Ethics approval(s) | Approved by the Institutional Review Board (IRB) Centre Muraz, University of California San Francisco Committee for Human Research, reference number: H2397-2758-01 and by the IRB Institute for Resource and Security Studies (IRSS), reference number: 019-2005/CE-CM |
| Health condition(s) or problem(s) studied | Malaria |
| Intervention | Subjects will be randomized to receive treatment with amodiaquine sulfadoxine pyrimethamine or artemether lumefantrine. Subjects in amodiaquine group will receive placebo to ensure the same number of doses in the two groups. Repeated therapy will be quinine. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Amodiaquine sulfadoxine pyrimethamine and artemether lumefantrine |
| Primary outcome measure | The risk of clinical and parasitological treatment failure after 28 days of follow-up. Pairwise comparisons between regimens will be made on based on a per protocol analysis. |
| Secondary outcome measures | 1. Risk of clinical failure after 14 days of follow-up 2. Risk of rescue therapy after 28 days of follow-up 3. Risk of fever during the first 3 days of follow-up: presence or absence of objective fever (axillary temperature >37.5 °C) or patient report of fever on days 1, 2, 3 4. Risk of parasitemia on follow-up days 2 and 3: proportion of positive versus negative thick blood smears on days 2 and 3 5. Change in mean hemoglobin from day 0 to 28 or day of repeat therapy 6. Proportion gametocytemic: presence versus absence of gametocytes on any follow-up thick blood smear; proportion gametocytemic on days 2, 3, 7, 14, 21, and 28 7. Risk of serious adverse events: proportion of patients experiencing any serious adverse event in each treatment group during the 28-day follow-up period, excluding treatment failures 8. Risk of adverse events of moderate or greater severity, at least possibly related to the study medications, excluding treatment failures |
| Overall study start date | 02/08/2005 |
| Completion date | 22/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 521 |
| Key inclusion criteria | 1. Age ≥6 months 2. Fever (≥37.5 or history of fever in the last 24 hours) 3. Provision of informed consent 4. P. falciparum mono infection 5. Parasite density >2000 microliters and ≥200,000 microliters |
| Key exclusion criteria | 1. Evidence of severe malaria 2. History of side effects to the investigational product 3. Pregnancy 4. Repeated vomiting of study medication on day 0 5. Hemoglobin <5 g/Dl 6. Evidence of concomitant febrile illness |
| Date of first enrolment | 02/08/2005 |
| Date of final enrolment | 22/12/2005 |
Locations
Countries of recruitment
- Burkina Faso
Study participating centre
399 Avenue de la Liberte
Bobo-Dioulasso
01
Burkina Faso
01
Burkina Faso
Sponsor information
Institute of Research in Health Sciences (Institut de Recherches en Sciences de la Sante [IRSS]) (Burkina Faso)
Government
Government
399 Avenue de la Liberte
P O Box 545
Bobo-Dioulasso
01
Burkina Faso
| Phone | +226 20981880 |
|---|---|
| jbouedraogo.irss@fasonet.bf | |
"ROR" |
https://ror.org/05m88q091 |
Funders
Funder type
Government
Fogarty International Center (part of the National Institutes of Health (FIC-NIH), D43 TW01506-05 (subcontract TW/8420599)
No information available
National Budget of Institut de Recherches en Sciences de la Sante (IRSS) and International Atomic Energy Agency (IAEA) RAF 6/025
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 10/02/2007 | No | No |
