Therapeutic Efficacy Study of Pyrimethamine/Sulfdoxine (Fansidar®) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon
Information source: Walter Reed Army Institute of Research (WRAIR)
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Condition(s) targeted: Malaria, Vivax; Malaria, Falciparum
Intervention: Pyrimethamine/sulfdoxine (Fansidar) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Walter Reed Army Institute of Research (WRAIR) Official(s) and/or principal investigator(s):
Alan Magill, MD, Principal Investigator, Affiliation: Walter Reed Army Institute of Research (WRAIR)
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.
Clinical Details
Official title: Therapeutic Efficacy Study of Pyrimethamine / Sulfdoxine (Fansidar®) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Determine the efficacy of pyrimethamine/sulfdoxine (Fansidar) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon.
Eligibility
Minimum age: 6 Months.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Naval Medical Research Center Detachment, Lima, Peru
Additional Information
Starting date: January 1998
Last updated: July 26, 2010
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