Status:
COMPLETED
Antimalarial Drug Resistance in Mali
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Malaria Research and Training Center, Bamako, Mali
Conditions:
Malaria
Eligibility:
All Genders
6-59 years
Phase:
NA
Brief Summary
Resistance of Plasmodium falciparum (malaria) to current antimalarial drugs and the continuing development of resistance to new antimalarial formulations is one of the major obstacles to effective mal...
Detailed Description
Resistance of Plasmodium falciparum to current antimalarial drugs and the continuing development of resistance to new antimalarial formulations is one of the major obstacles to effective malaria contr...
Eligibility Criteria
Inclusion
- Aged 6-59 months
- Absence of severe malnutrition (defined as a child whose weight-for-height is below 3 standard deviations of less than 70% of the median of World Health Organization (WHO) reference values, or who has symmetrical edema involving at least the feet)
- A slide-confirmed infection with P. falciparum only (i.e. no mixed infections)
- Initial parasite density between 2,000 and 200,000 asexual parasites per microliter.
- Absence of general danger signs among children \< 5 years (inability to drink or breastfeed; vomiting everything; recent history of convulsions; lethargy or unconsciousness; inability to sit or stand up) or other signs of severe and complicated falciparum malaria according to WHO definitions
- Measured axillary temperature ≥ 37.5 °C
- Ability to attend stipulated follow-up visits
- Informed consent provided by parent/guardian
- Absence of history of hypersensitivity reactions to any of the drugs being evaluated
Exclusion
- Aged \< 6 or \>59 months
- Severe malnutrition (defined as a child whose weight-for-height is below 3 standard deviations of less than 70% of the median of WHO reference values, or who has symmetrical edema involving at least the feet)
- No slide confirmed infection with P. falciparum or a mixed infection that includes a non P. falciparum species
- Initial parasite density \< 2,000 or \> 200,000 asexual parasites per microliter.
- Presence of general danger signs among children \< 5 years (inability to drink or breastfeed; vomiting everything; recent history of convulsions; lethargy or unconsciousness; inability to sit or stand up) or other signs of severe and complicated falciparum malaria according to WHO definitions
- Measured axillary temperature \<37.5 °C
- Inability to attend stipulated follow-up visits
- Unwilling to provide informed consent provided by parent/guardian
- History of hypersensitivity reactions to any of the drugs being evaluated
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
1011 Patients enrolled
Trial Details
Trial ID
NCT00127998
Start Date
July 1 2005
Last Update
August 16 2006
Active Locations (3)
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1
Faladje Missionary Dispensary
Faladié, Mali
2
Koro Health Center
Koro, Mali
3
Pongono Community Health Center
Pongono, Mali