Status:
SUSPENDED
Safety and Efficacy of Chloroquine Associated With Dehydroepiandrosterone Sulphate to Treat Uncomplicated Falciparum Malaria
Lead Sponsor:
Université Victor Segalen Bordeaux 2
Conditions:
Malaria
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
This study aims to evaluate the safety and efficacy of a standard chloroquine drug regimen administration supplemented with dehydroepiandrosterone sulfate against drug-resistant malaria.
Detailed Description
Worldwide progression of Plasmodium falciparum chloroquine (CQ), amodiaquine and sulfadoxine-pyrimethamine resistance leaves few alternative for the control of malaria, particularly in Africa. For som...
Eligibility Criteria
Inclusion
- signing an informed consent (informed consent was given by legal guardian for children);
- age egal or more than 15 years;
- fever (axillary temperature egal or more than 37.5 °C and less than 40°C) or a history of fever within the last 24 hours;
- no sign suggestive of other febrile illness;
- absence of signs of complicated malaria (WHO criteria);
- willingness to participate in follow-up for 14 days
- a positive thick blood film for P. falciparum without other detectable infectious microorganisms
Exclusion
- patients taking glucocorticoids or other immuno-suppressive drugs, or indicating recent antimalarial drug history (verbal questionnaire);
- severe malaria;
- mixed infections;
- women using contraceptives;
- pregnant women;
- breast-feeding women.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2002
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00442403
Start Date
April 1 2002
End Date
September 1 2002
Last Update
March 1 2007
Active Locations (1)
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1
Institute of Medical Research and study of Medicinal Plants, Medical Research Center
Yaoundé, Cameroon