Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers

Completed

• Conditions: Plasmodium Falciparum

• Registration Number: NCT02895568
• Lead Sponsor: University of Oxford

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-09-05
• Study First Posted: 2016-09-09
• Study Start: 2016-09-16
• Primary Completion: 2018-09-06
• Study Completion: 2018-09-06
• Status Verified: 2018-11
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 399

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent prevalence of kelch13 mutants (marker of resistance to artemisinins)	2 years

Secondary Outcome Measures

Name	Time	Method
Percent prevalence of specimens with pfmdr1 copy number >1 (marker of resistance to mefloquine)	2 years
Visualization and dissemination of molecular marker prevalence data to inform public health officials, researchers, policymakers and key stakeholders	2 yeas

Trial Locations

Locations (1)

Study clinic; 🇹🇩 Kome, Doba, Chad