Status:
COMPLETED
Therapeutic Efficacy Study of Pyrimethamine/Sulfdoxine (Fansidar®) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon
Lead Sponsor:
Walter Reed Army Institute of Research (WRAIR)
Conditions:
Malaria, Vivax
Malaria, Falciparum
Eligibility:
All Genders
6+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the efficacy of pyrimethamine/sulfdoxine (Fansidar®) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon. Reports in the mid 1990s in...
Eligibility Criteria
Inclusion
- Pf monoinfection with asexual forms
- Parasite density of greater than 500 per mcl and less than 200 parasites per oil immersion field (MINSA quantification of "4 plus")
- Age \> 6 months
- Temperature greater than 38C (101F)
- Available and willing to return for follow-up
Exclusion
- Presence of any of the following "danger" signs or symptoms suggestive of severe malaria
- Not able to drink or breastfeed
- Repeated vomiting (unable to keep anything down)
- Convulsions during present illness
- Lethargic or unconscious state
- Unable to sit or stand up
- Respiratory distress
- Jaundice (observation) or dark urine (by history)
- Severe anemia (Hemoglobin \< 5 g/dl)
- Hypotension (systolic BP \< 80 mm Hg in adults and \< 50 mm Hg in children under the age of 5
- Presence of another significant illness or chronic disease
- Known pregnancy (by history)
- History of hypersensitivity to medication used in the test
Key Trial Info
Start Date :
January 1 1998
Trial Type :
INTERVENTIONAL
End Date :
August 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00951106
Start Date
January 1 1998
End Date
August 1 2009
Last Update
July 27 2010
Active Locations (1)
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1
Naval Medical Research Center Detachment
Lima, Peru