Clinical trial NCT02895568: Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers
Official title: Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers in Komé, Doba, Republic of Chad
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plasmodium Falciparum
Keywords: Antimalarial drug
Resistance
Republic of Chard
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Worldwide Antimalarial Resistance Network
name: Mahidol University
First posted: 2016-09-09
Enrollment: 399
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent prevalence of kelch13 mutants (marker of resistance to artemisinins)
timeFrame: 2 years
Secondary outcomes:
measure: Percent prevalence of specimens with pfmdr1 copy number >1 (marker of resistance to mefloquine)
timeFrame: 2 years
measure: Visualization and dissemination of molecular marker prevalence data to inform public health officials, researchers, policymakers and key stakeholders
timeFrame: 2 yeas
Other outcomes:
Locations:
city: Kome
country: Chad
facility: Study clinic
state: Doba
Study officials:
References:
citation: 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.