Clinical trial NCT00951106: Therapeutic Efficacy Study of Pyrimethamine/Sulfdoxine (Fansidar®) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon
Official title: Therapeutic Efficacy Study of Pyrimethamine / Sulfdoxine (Fansidar®) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria, Vivax
Malaria, Falciparum
Keywords: Peru
Sulfadoxine-pyrimethamine
Drug resistance
Lead sponsor: Walter Reed Army Institute of Research (WRAIR)
Sponsor class: FED
First posted: 2009-08-04
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 indicated that Fansidar was failing to cure patients with confirmed falciparum malaria. The study design was based on accepted WHO parasitological and clinical outcomes to determine the overall efficacy of Fansider and inform the Peruvian National Malaria Control authorities as to the continued wisdom of recommending Fansidar as first line treatment for uncomplicated falciparum malaria in the Peruvian Amazon.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Determine the efficacy of pyrimethamine/sulfdoxine (Fansidar) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon.
timeFrame: 28 days after dose
Secondary outcomes:
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Naval Medical Research Center Detachment
Study officials:
affiliation: Walter Reed Army Institute of Research (WRAIR)
name: Alan Magill, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.