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Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers

Sponsor
University of Oxford (Other)
Overall Status
Completed
CT.gov ID
NCT02895568
Collaborator
Worldwide Antimalarial Resistance Network (Other), Mahidol University (Other)
399
Enrollment
1
Location
23.7
Actual Duration (Months)
16.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to measure prevalence of established and candidate molecular markers of drug resistant malaria at Komé, Doba, Republic of Chad.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a cross-sectional, observational study using dried blood samples collected from P. falciparum-infected individuals at the time of malaria diagnosis to measure the prevalence of known and candidate molecular markers of resistance to artemisinin and non-artemisinin ACT partner drugs. A maximum of 200 participants will be enrolled at each participating site per year. Study duration is 2 years. Therefore total participant is up to 400.

    Prospective participants will have blood collected for dried blood spot (DBS) study sample after providing informed consent. Individuals with confirmed P. falciparum infection will have DBS samples included for molecular analyses for known and candidate molecular markers of antimalarial drug resistance.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    399 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers in Komé, Doba, Republic of Chad
    Actual Study Start Date :
    Sep 16, 2016
    Actual Primary Completion Date :
    Sep 6, 2018
    Actual Study Completion Date :
    Sep 6, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Percent prevalence of kelch13 mutants (marker of resistance to artemisinins) [2 years]

    Secondary Outcome Measures

    1. Percent prevalence of specimens with pfmdr1 copy number >1 (marker of resistance to mefloquine) [2 years]

    2. Visualization and dissemination of molecular marker prevalence data to inform public health officials, researchers, policymakers and key stakeholders [2 yeas]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Participants must meet all of the inclusion criteria to participate in the study.

    • Patients (6 months - 75 years) with confirmed uncomplicated P. falciparum infection

    • Written informed consent obtained

    Exclusion Criteria:
    • Patients presenting signs of severe malaria will be excluded from the survey to prevent any delay in the management of the patient.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Study clinic Kome Doba Chad

    Sponsors and Collaborators

    • University of Oxford
    • Worldwide Antimalarial Resistance Network
    • Mahidol University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Oxford
    ClinicalTrials.gov Identifier:
    NCT02895568
    Other Study ID Numbers:
    • WWARN1603
    First Posted:
    Sep 9, 2016
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by University of Oxford
    Antimalarial drug
    Resistance
    Republic of Chard
    Additional relevant MeSH terms:
    Malaria

    Study Results

    No Results Posted as of Apr 7, 2022