Overview

SP Resistance and Falciparum Malaria Transmission

Status:
Withdrawn
Trial end date:
2006-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to study resistance to current malaria treatments and affordable alternatives for uncomplicated malaria. Resistance occurs in areas where these treatments are used frequently. This study may help prevent future resistance. About 150 residents in Buenaventura, Colombia will participate. They will have uncomplicated malaria and they will be followed for 28 days after treatment. Physical exams and blood draws are included in study visits.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Pyrimethamine
Sulfadoxine
Criteria
Inclusion Criteria:

Age more than 5 years Positive blood smear for falciparum malaria Informed consent from
participant or parent Intention to remain in the study area for at least 4 weeks from the
time of enrollment

Exclusion Criteria:

Mixed Plasmodium infection Parasitemia > 10% Hematocrit < 15% Respiratory distress
Spontaneous bleeding (from gums, nose, gastrointestinal tract, etc.) Recent seizures or
coma Prostration or weakness, so that the patient cannot sit or walk, with no obvious
neurological explanation Inability to drink Persistent vomiting History of allergy or
adverse reaction to sulfadoxine-pyrimethamine (SP) or sulfa drugs Known pregnancy