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Completed

NCT Number: NCT02895568

Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers

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

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Key information

Conditions

Plasmodium Falciparum Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

6 month–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Study clinic

Komé, Doba, Chad

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percent prevalence of kelch13 mutants (marker of resistance to artemisinins)

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 2 years

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

    Time frame: 2 yeas

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Mahidol University
  • Worldwide Antimalarial Resistance Network

Registry information

Official study title

Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers in Komé, Doba, Republic of Chad

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 9, 2016
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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