Prevalence Survey of Antimalarial Drug Resistance Markers at Sites in India

Plasmodium Falciparum Clinical Trial

Official title:

Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers at Sites in India

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03219281
• Other study ID #: WWARN 1701
• Status: Not yet recruiting
• Phase: N/A
• First received: July 13, 2017
• Last updated: July 17, 2017
• Start date: July 2017
• Est. completion date: July 2018

Study information

• Verified date: July 2017
• Source: University of Oxford
• Contact: Mehul Dhorda, PhD
• Phone: +66 (0) 23 54 91 28
• Email: mehul.dhorda[@]wwarn.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 sites per year. Study duration is 1 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: Not yet recruiting
• Enrollment: 400
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 75 Years

Eligibility

Inclusion Criteria:

• 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
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	St. John's Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent prevalence of kelch13 mutants (marker of resistance to artemisinins)	To estimate the prevalence of established and candidate molecular markers of antimalarial drug resistance at specified geographic locations	1 year
Secondary	Percent prevalence of specimens with pfmdr1 copy number >1 (marker of resistance to mefloquine)	To map the geographical and temporal changes in prevalence of molecular markers of antimalarial drug resistance at sites in Kalahandi District and Shillong, India.	1 year
Secondary	Visualization and dissemination of molecular marker prevalence data to inform public health officials, researchers, policymakers and key stakeholders	To map the geographical and temporal changes in prevalence of molecular markers of antimalarial drug resistance at sites in Kalahandi District and Shillong, India.	1 year