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

Walter Reed Army Institute of Research (WRAIR)

Status

Completed

Conditions

Malaria, Falciparum

Malaria, Vivax

Treatments

Drug: Pyrimethamine/sulfdoxine (Fansidar)

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00951106

WRAIR #719

Details and patient eligibility

About

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.

Sex

All

Ages

6+ months old

Volunteers

No Healthy Volunteers

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