Status:
COMPLETED
In Vivo and in Vitro Efficacy of Antimalarial Treatments in Children in Burkina Faso
Lead Sponsor:
Centre Muraz
Collaborating Sponsors:
Institute of Tropical Medicine, Belgium
Conditions:
Malaria
Eligibility:
All Genders
6-15 years
Phase:
PHASE4
Brief Summary
Resistance to antimalarial drugs represents a major obstacle for controlling malaria in endemic countries, so that most sub-Saharan countries have changed their antimalarial drug policy to the new Art...
Detailed Description
Plasmodium falciparum resistance to antimalarial drugs represents the major drawback and obstacle for controlling malaria in endemic countries; that's why most sub-Saharan countries have changed their...
Eligibility Criteria
Inclusion
- Age 6 - 59 months
- Weight \> 5 kg
- Mono-infection with P. falciparum
- Parasitemia of 4,000-200,000 asexual parasites per µl
- Fever: \> 37.5 °C or history of fever in the preceding 24 hours
- Haemoglobin \> 5.0 g/dl
- Signed informed consent by the parents or guardians
- Parents' or guardians' willingness and ability to comply with the study protocol for the duration of the trial.
Exclusion
- Participation in any other clinical trial during the previous 30 days
- Known hypersensitivity to the study drugs
- Severe and/or complicated malaria (cases will be referred to Bobo-Dioulasso University hospital for treatment)
- Danger signs: not able to drink or breast-feed, vomiting (\> twice in 24hours), recent history of convulsions (\>1 in 24h), unconscious state, unable to sit or stand;
- Known intercurrent illness or any condition which would place the subject at undue risk or interfere with the results of the study.
- Severe malnutrition (weight for height \<70% of the median NCHS/WHO reference)
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT00808951
Start Date
December 1 2008
End Date
February 1 2011
Last Update
August 3 2015
Active Locations (1)
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1
Tinto Halidou
Bobo-Dioulasso, Houet, Burkina Faso, 01