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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00951106

Enrollment

Unknown

Registered

2009-08-04

Start date

1998-01-31

Completion date

2009-08-31

Last updated

2010-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria, Falciparum, Malaria, Vivax

Keywords

Peru, Sulfadoxine-pyrimethamine, Drug resistance

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.

Interventions

DRUGPyrimethamine/sulfdoxine (Fansidar)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to No maximum

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

Design outcomes

Primary

Measure	Time frame
Determine the efficacy of pyrimethamine/sulfdoxine (Fansidar) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon.	28 days after dose

Countries

Peru

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026