NCT00299247

Brief Summary

The purpose of this study is to study resistance to current malaria treatments and affordable alternatives for uncomplicated malaria. Resistance occurs in areas where these treatments are used frequently. This study may help prevent future resistance. About 150 residents in Buenaventura, Colombia will participate. They will have uncomplicated malaria and they will be followed for 28 days after treatment. Physical exams and blood draws are included in study visits.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2010

First QC Date

March 3, 2006

Last Update Submit

January 28, 2019

Conditions

Plasmodium Falciparum Malaria

Keywords

Malaria, Plasmodium falciparum, drug resistance, Colombia

Interventions

sulfadoxine/pyrimethamineDRUG

Eligibility Criteria

Age5 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age more than 5 years Positive blood smear for falciparum malaria Informed consent from participant or parent Intention to remain in the study area for at least 4 weeks from the time of enrollment

You may not qualify if:

  • Mixed Plasmodium infection Parasitemia \> 10% Hematocrit \< 15% Respiratory distress Spontaneous bleeding (from gums, nose, gastrointestinal tract, etc.) Recent seizures or coma Prostration or weakness, so that the patient cannot sit or walk, with no obvious neurological explanation Inability to drink Persistent vomiting History of allergy or adverse reaction to sulfadoxine-pyrimethamine (SP) or sulfa drugs Known pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Malaria Vaccine and Drug Development Center

Cali, Colombia

Location

Universidad del Valle Sede San Fernando

Cali, Colombia

Location

MeSH Terms

Conditions

Malaria, FalciparumMalaria

Interventions

fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

March 3, 2006

First Posted

March 6, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

January 30, 2019

Record last verified: 2010-01

Locations

CO(2)