Therapeutic Efficacy Study of Pyrimethamine/Sulfdoxine (Fansidar®) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon
NCT ID: NCT00951106
Last Updated: 2010-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
1998-01-31
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pyrimethamine/sulfdoxine (Fansidar)
Pyrimethamine/sulfdoxine (Fansidar)
Pyrimethamine/sulfdoxine (Fansidar)
Interventions
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Pyrimethamine/sulfdoxine (Fansidar)
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
6 Months
ALL
No
Sponsors
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Walter Reed Army Institute of Research (WRAIR)
FED
Responsible Party
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WRAIR
Principal Investigators
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Alan Magill, MD
Role: PRINCIPAL_INVESTIGATOR
Walter Reed Army Institute of Research (WRAIR)
Locations
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Naval Medical Research Center Detachment
Lima, , Peru
Countries
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References
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Magill AJ, Zegarra J, Garcia C, Marquino W, Ruebush TK 2nd. Efficacy of sulfadoxine-pyrimethamine and mefloquine for the treatment of uncomplicated Plasmodium falciparum malaria in the Amazon basin of Peru. Rev Soc Bras Med Trop. 2004 May-Jun;37(3):279-81. doi: 10.1590/s0037-86822004000300015.
Huaman MC, Roncal N, Nakazawa S, Long TT, Gerena L, Garcia C, Solari L, Magill AJ, Kanbara H. Polymorphism of the Plasmodium falciparum multidrug resistance and chloroquine resistance transporter genes and in vitro susceptibility to aminoquinolines in isolates from the Peruvian Amazon. Am J Trop Med Hyg. 2004 May;70(5):461-6.
Bacon DJ, Tang D, Salas C, Roncal N, Lucas C, Gerena L, Tapia L, Llanos-Cuentas AA, Garcia C, Solari L, Kyle D, Magill AJ. Effects of point mutations in Plasmodium falciparum dihydrofolate reductase and dihydropterate synthase genes on clinical outcomes and in vitro susceptibility to sulfadoxine and pyrimethamine. PLoS One. 2009 Aug 26;4(8):e6762. doi: 10.1371/journal.pone.0006762.
Other Identifiers
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WRAIR #719
Identifier Type: -
Identifier Source: org_study_id
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