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.

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Key information

Conditions

Malaria, Vivax Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naval Medical Research Center Detachment

Lima, Peru

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pyrimethamine/sulfdoxine (Fansidar)

Drug

Primary outcomes

Determine the efficacy of pyrimethamine/sulfdoxine (Fansidar) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon.

Time frame: 28 days after dose

Sponsors and collaborators

Lead sponsor

Walter Reed Army Institute of Research (WRAIR)

Fed

Registry information

Official study title

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

Important dates

Study start: 1998
Primary completion: 1999
Study completion: 2009
First posted: Aug 4, 2009
Registry last updated: Jul 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed