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

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ClinicalTrials.gov Identifier: NCT00951106
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : July 27, 2010
Sponsor:
Information provided by:
Walter Reed Army Institute of Research (WRAIR)

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.

Condition or disease Intervention/treatment Phase
Malaria, Vivax Malaria, Falciparum Drug: Pyrimethamine/sulfdoxine (Fansidar) Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 1998
Actual Primary Completion Date : June 1999
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pyrimethamine/sulfdoxine (Fansidar)
Pyrimethamine/sulfdoxine (Fansidar)
Drug: Pyrimethamine/sulfdoxine (Fansidar)



Primary Outcome Measures :
  1. Determine the efficacy of pyrimethamine/sulfdoxine (Fansidar) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon. [ Time Frame: 28 days after dose ]


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Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: COL Alan Magill, WRAIR
ClinicalTrials.gov Identifier: NCT00951106     History of Changes
Other Study ID Numbers: WRAIR #719
First Posted: August 4, 2009    Key Record Dates
Last Update Posted: July 27, 2010
Last Verified: July 2010

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
Fanasil, pyrimethamine drug combination
Sulfadoxine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents