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

This study has been completed.
Sponsor:
Information provided by:
Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:
NCT00951106
First received: July 30, 2009
Last updated: July 26, 2010
Last verified: July 2010
History of Changes

July 30, 2009
July 26, 2010
January 1998
June 1999   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00951106 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Therapeutic Efficacy Study of Pyrimethamine/Sulfdoxine (Fansidar®) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon
Therapeutic Efficacy Study of Pyrimethamine / Sulfdoxine (Fansidar®) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon

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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Malaria, Vivax
  • Malaria, Falciparum
Drug: Pyrimethamine/sulfdoxine (Fansidar)
Experimental: Pyrimethamine/sulfdoxine (Fansidar)
Pyrimethamine/sulfdoxine (Fansidar)
Intervention: Drug: Pyrimethamine/sulfdoxine (Fansidar)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
August 2009
June 1999   (final data collection date for primary outcome measure)

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
Both
6 Months and older
No
Contact information is only displayed when the study is recruiting subjects
Peru
 
NCT00951106
WRAIR #719
No
COL Alan Magill, WRAIR
Walter Reed Army Institute of Research (WRAIR)
Not Provided
Principal Investigator: Alan Magill, MD Walter Reed Army Institute of Research (WRAIR)
Walter Reed Army Institute of Research (WRAIR)
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP