NCT00951106

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 1998

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 1999

Completed
10.2 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2009

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
Last Updated

July 27, 2010

Status Verified

July 1, 2010

Enrollment Period

1.4 years

First QC Date

July 30, 2009

Last Update Submit

July 26, 2010

Conditions

Malaria, VivaxMalaria, Falciparum

Keywords

PeruSulfadoxine-pyrimethamineDrug resistance

Outcome Measures

Primary Outcomes (1)

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

    28 days after dose

Study Arms (1)

Pyrimethamine/sulfdoxine (Fansidar)

EXPERIMENTAL

Pyrimethamine/sulfdoxine (Fansidar)

Drug: Pyrimethamine/sulfdoxine (Fansidar)

Interventions

Pyrimethamine/sulfdoxine (Fansidar)DRUG
Pyrimethamine/sulfdoxine (Fansidar)

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naval Medical Research Center Detachment

Lima, Peru

Location

Related Publications (3)

  • 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.

    PMID: 15330070RESULT

  • 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.

    PMID: 15155976RESULT

  • 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.

    PMID: 19707564DERIVED

MeSH Terms

Conditions

Malaria, VivaxMalaria, Falciparum

Interventions

Pyrimethaminefanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

PyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Alan Magill, MD

    Walter Reed Army Institute of Research (WRAIR)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

July 30, 2009

First Posted

August 4, 2009

Study Start

January 1, 1998

Primary Completion

June 1, 1999

Study Completion

August 1, 2009

Last Updated

July 27, 2010

Record last verified: 2010-07

Locations

PE(1)