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CompletedNCT02895568Updated Apr 7, 2022

Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers

An observational study in Plasmodium Falciparum, sponsored by University of Oxford. Completed at 1 site in Chad. Open to participants aged 6 Months to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-07.

Sponsored by University of Oxford · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
399
Ages
6 Months to 75 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Plasmodium Falciparum

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Keywords

  • Antimalarial drug
  • Resistance
  • Republic of Chard
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In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 399 is below the median of 600 across 218 observational studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Study participants will be the patients presenting at study clinics with signs and symptoms of malaria (including but not limited to headache, body aches, fever, chills, and weakness) and confirmed P. falciparum infection.

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

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

Observational model
Other
Time perspective
Cross-sectional
Enrollment
399 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

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

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Study locations

1 site
  • Study clinic
    Kome, Doba, Chad
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References and documents

Publications

  • Das S, Kerah-Hinzoumbe C, Kebfene M, Srisutham S, Nagorngar TY, Saralamba N, Vongpromek R, Khomvarn T, Sibley CH, Guerin PJ, Imwong M, Dhorda M. Molecular surveillance for operationally relevant genetic polymorphisms in Plasmodium falciparum in Southern Chad, 2016-2017. Malar J. 2022 Mar 12;21(1):83. doi: 10.1186/s12936-022-04095-9. PubMed 35279140 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02895568
Lead sponsor
University of Oxford
Collaborators
Worldwide Antimalarial Resistance Network, Mahidol University
Responsible party
Sponsor
First posted
Sep 9, 2016
Start date
Sep 16, 2016
Primary completion
Sep 6, 2018
Completion
Sep 6, 2018
Last update
Apr 7, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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