SP Resistance and Falciparum Malaria Transmission

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00299247
First received: March 3, 2006
Last updated: August 26, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Plasmodium Falciparum Malaria
Drug: sulfadoxine/pyrimethamine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SP Resistance Markers and Falciparum Malaria Transmission

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 150
Estimated Study Completion Date: December 2006
Estimated Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299247

Locations
Colombia
Malaria Vaccine and Drug Development Center
Cali, Colombia
Universidad del Valle Sede San Fernando
Cali, Colombia
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00299247     History of Changes
Other Study ID Numbers: 03-246
Study First Received: March 3, 2006
Last Updated: August 26, 2010
Health Authority: Unspecified

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Malaria, Plasmodium falciparum, drug resistance, Colombia

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on August 01, 2014