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

Primary Purpose

Malaria, Vivax, Malaria, Falciparum

Status
Completed
Phase
Not Applicable
Locations
Peru
Study Type
Interventional
Intervention
Pyrimethamine/sulfdoxine (Fansidar)
Sponsored by
Walter Reed Army Institute of Research (WRAIR)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria, Vivax focused on measuring Peru, Sulfadoxine-pyrimethamine, Drug resistance

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Naval Medical Research Center Detachment

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pyrimethamine/sulfdoxine (Fansidar)

Arm Description

Pyrimethamine/sulfdoxine (Fansidar)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 30, 2009
Last Updated
July 26, 2010
Sponsor
Walter Reed Army Institute of Research (WRAIR)
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1. Study Identification

Unique Protocol Identification Number
NCT00951106
Brief Title
Therapeutic Efficacy Study of Pyrimethamine/Sulfdoxine (Fansidar®) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon
Official Title
Therapeutic Efficacy Study of Pyrimethamine / Sulfdoxine (Fansidar®) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
June 1999 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Walter Reed Army Institute of Research (WRAIR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Vivax, Malaria, Falciparum
Keywords
Peru, Sulfadoxine-pyrimethamine, Drug resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Arm Title
Pyrimethamine/sulfdoxine (Fansidar)
Arm Type
Experimental
Arm Description
Pyrimethamine/sulfdoxine (Fansidar)
Intervention Type
Drug
Intervention Name(s)
Pyrimethamine/sulfdoxine (Fansidar)
Primary Outcome Measure Information:
Title
Determine the efficacy of pyrimethamine/sulfdoxine (Fansidar) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon.
Time Frame
28 days after dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Magill, MD
Organizational Affiliation
Walter Reed Army Institute of Research (WRAIR)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Research Center Detachment
City
Lima
Country
Peru

12. IPD Sharing Statement

Citations:
PubMed Identifier
15330070
Citation
Magill AJ, Zegarra J, Garcia C, Marquino 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. doi: 10.1590/s0037-86822004000300015.
Results Reference
result
PubMed Identifier
15155976
Citation
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 isolates from the Peruvian Amazon. Am J Trop Med Hyg. 2004 May;70(5):461-6.
Results Reference
result
PubMed Identifier
19707564
Citation
Bacon DJ, Tang D, Salas C, Roncal N, Lucas C, Gerena L, Tapia L, Llanos-Cuentas AA, Garcia C, Solari L, Kyle D, Magill AJ. Effects of point mutations in Plasmodium falciparum dihydrofolate reductase and dihydropterate synthase genes on clinical outcomes and in vitro susceptibility to sulfadoxine and pyrimethamine. PLoS One. 2009 Aug 26;4(8):e6762. doi: 10.1371/journal.pone.0006762.
Results Reference
derived

Learn more about this trial

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

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