Status:
COMPLETED
Tolerability and Efficacy of CD+A Compared to AQ+SP for the Treatment of P.Falciparum Malaria in Rwandan Children
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Institute of Tropical Medicine, Belgium
Conditions:
Malaria
Eligibility:
All Genders
12-59 years
Phase:
NA
Brief Summary
In 2005-2006, a clinical trial was carried out to test safety, tolerability and efficacy of the combination chlorproguanil-dapsone+artesunate (CD+A): 800 children aged 12-59 months with uncomplicated ...
Detailed Description
Between 2001 and 2006, as an interim strategy, Rwanda chose amodiaquine+ sulfadoxine-pyrimethamine (AQ+SP) as the first line anti-malaria treatment. Although the clinical response to this combination ...
Eligibility Criteria
Inclusion
- Age 12-59 months;
- Weight ≥5 kg;
- Monoinfection with P. falciparum;
- Parasite density between 2,000-200,000/µL;
- Fever (axillary body temperature =\>37.5C) or history of fever in the preceding 24 hours;
- Packed Cell Volume (PCV) \>21%.
Exclusion
- Severe malaria;
- Mixed malaria infection;
- Any other concomitant illness or underlying disease;
- Known allergy to the study drugs being used in this trial;
- Clear history of adequate antimalarial treatment in the previous 72 hours.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00461578
Start Date
April 1 2005
End Date
October 1 2006
Last Update
April 18 2007
Active Locations (1)
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1
Programme Nationale Integre de Lutte contre le Paludisme
Kigali, Rwanda, BP 2514