Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers

Plasmodium Falciparum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895568
• Other study ID #: WWARN1603
• Status: Completed
• Start date: September 16, 2016
• Est. completion date: September 6, 2018

Study information

• Verified date: November 2018
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: September 6, 2018
• Est. primary completion date: September 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malaria
• Plasmodium Falciparum

Locations

Country	Name	City	State
Chad	Study clinic	Kome	Doba

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	Mahidol University, Worldwide Antimalarial Resistance Network

Country where clinical trial is conducted

Chad, 

References & Publications (1)

Das S, Kérah-Hinzoumbé C, Kebféné M, Srisutham S, Nagorngar TY, Saralamba N, Vongpromek R, Khomvarn T, Sibley CH, Guérin 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent prevalence of kelch13 mutants (marker of resistance to artemisinins)		2 years
Secondary	Percent prevalence of specimens with pfmdr1 copy number >1 (marker of resistance to mefloquine)		2 years
Secondary	Visualization and dissemination of molecular marker prevalence data to inform public health officials, researchers, policymakers and key stakeholders		2 yeas