Therapeutic Efficacy Study of Pyrimethamine/Sulfdoxine (Fansidar®) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon - Full Text View

Sponsor:	Walter Reed Army Institute of Research (WRAIR)
Information provided by:	Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:	NCT00951106

Purpose

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.

Condition	Intervention
Malaria, Vivax Malaria, Falciparum	Drug: Pyrimethamine/sulfdoxine (Fansidar)

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Therapeutic Efficacy Study of Pyrimethamine / Sulfdoxine (Fansidar®) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: Pyrimethamine Fansidar Sulfadoxine

U.S. FDA Resources

Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Primary Outcome Measures:

Determine the efficacy of pyrimethamine/sulfdoxine (Fansidar) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon. [ Time Frame: 28 days after dose ] [ Designated as safety issue: No ]

Study Start Date:	January 1998
Study Completion Date:	August 2009
Primary Completion Date:	June 1999 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pyrimethamine/sulfdoxine (Fansidar) Pyrimethamine/sulfdoxine (Fansidar)	Drug: Pyrimethamine/sulfdoxine (Fansidar)

Eligibility

Ages Eligible for Study:	6 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951106

Locations

Peru
Naval Medical Research Center Detachment
Lima, Peru

Sponsors and Collaborators

Walter Reed Army Institute of Research (WRAIR)

Investigators

Principal Investigator:

Alan Magill, MD

Walter Reed Army Institute of Research (WRAIR)

More Information

Publications:

Magill AJ, Zegarra J, Garcia C, Marquiño 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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	COL Alan Magill, WRAIR
ClinicalTrials.gov Identifier:	NCT00951106 History of Changes
Other Study ID Numbers:	WRAIR #719
Study First Received:	July 30, 2009
Last Updated:	July 26, 2010
Health Authority:	United States: Federal Government

Keywords provided by Walter Reed Army Institute of Research (WRAIR):

Peru
Sulfadoxine-pyrimethamine
Drug resistance

Additional relevant MeSH terms:

Malaria
Malaria, Falciparum
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine-pyrimethamine
Antimalarials

Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012