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SP Resistance and Falciparum Malaria Transmission

Primary Purpose

Plasmodium Falciparum Malaria

Status
Withdrawn
Phase
Phase 3
Locations
Colombia
Study Type
Interventional
Intervention
sulfadoxine/pyrimethamine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plasmodium Falciparum Malaria focused on measuring Malaria, Plasmodium falciparum, drug resistance, Colombia

Eligibility Criteria

5 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Malaria Vaccine and Drug Development Center
  • Universidad del Valle Sede San Fernando

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 3, 2006
Last Updated
January 28, 2019
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00299247
Brief Title
SP Resistance and Falciparum Malaria Transmission
Official Title
SP Resistance Markers and Falciparum Malaria Transmission
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
December 2006 (Anticipated)
Study Completion Date
December 2006 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
Detailed Description
Drug-resistant Plasmodium falciparum is a major threat to global public health and new strategies are needed to deter spread of resistance to available and forthcoming antimalarial drugs. This study seeks to contribute to understanding the molecular basis of spread of drug resistance in a setting with low level of sulfadoxine-pyrimethamine (SP) treatment failure. The objectives of this study are to compare the prevalence of dihydrofolate reductase (DHFR) and dihydropteroate synthase (DHPS) point mutations associated with SP resistance before and after SP treatment of uncomplicated Plasmodium falciparum malaria episodes and to measure parasite infectivity to Anopheles mosquitoes of post-treatment gametocytes with and without DHFR and DHPR mutations. Patients with uncomplicated falciparum malaria will receive a standard SP regimen and will be closely followed for 28 days. This study will add new knowledge of the understanding of ways in which resistance is spread and is expected to provide a sound basis for the future clinical evaluation of antimalarial drug combinations designed to prevent transmission of drug-resistance malaria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasmodium Falciparum Malaria
Keywords
Malaria, Plasmodium falciparum, drug resistance, Colombia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sulfadoxine/pyrimethamine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Malaria Vaccine and Drug Development Center
City
Cali
Country
Colombia
Facility Name
Universidad del Valle Sede San Fernando
City
Cali
Country
Colombia

12. IPD Sharing Statement

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SP Resistance and Falciparum Malaria Transmission

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