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

Malaria, Falciparum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951106
• Other study ID #: WRAIR #719
• Status: Completed
• Phase: N/A
• First received: July 30, 2009
• Last updated: July 26, 2010
• Start date: January 1998
• Est. completion date: August 2009

Study information

• Verified date: July 2010
• Source: Walter Reed Army Institute of Research (WRAIR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2009
• Est. primary completion date: June 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Malaria, Vivax

Intervention

Drug:
• Pyrimethamine/sulfdoxine (Fansidar)

Locations

Country	Name	City	State
Peru	Naval Medical Research Center Detachment	Lima

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed Army Institute of Research (WRAIR)

Country where clinical trial is conducted

Peru, 

References & Publications (2)

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 iso — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the efficacy of pyrimethamine/sulfdoxine (Fansidar) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon.		28 days after dose	No