Malaria Genetic Surveillance

Plasmodium Falciparum and Plasmodium Vivax Clinical Trial

Official title:

Genetic Epidemiology of Malaria and Associated Antimalarial Drug Resistance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03384498
• Other study ID #: BIOINF1602
• Status: Recruiting
• Start date: October 2016
• Est. completion date: January 31, 2023

Study information

• Verified date: March 2022
• Source: University of Oxford
• Contact: Olivo Miotto, MD
• Email: Olivo[@]tropmedres.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is to determine the prevalence and geographical distribution of antimalarial drug resistance-linked genetic mutations in clinical P. falciparum and/or P.Vivax infection in the Greater Mekong Subregion

Description:

This is a prospective observational study of patients with clinical Plasmodium falciparum and/or Plasmodium Viviax infection using parasite DNA from point-of-care fingerprick dried blood spot samples as well as a short survey on patient demographics, employment, travel, and mobile phone use to study P. falciparum parasite genotypes, population characteristics, and gene flow patterns.

On inclusion in the study and before standard treatment is administered, dried blood spots (DBS) will be obtained through fingerprick blood sampling from patients, with two or three blood spots on one piece of filter paper being obtained from each patient. Each blood spot will contain ~20µl of blood, for a total of ~ 40-60 uL of blood being collected from each patient for the study.

In order to have a greater understanding of the possible sites of malaria transmission and to relate genetic diversity to geographic location, patients or their parents/guardians will also be asked a short set of questions on demographics, their places of residence and work, recent mobile phone use, and their history of travel. The basic questions on phone utilisation will provide information on the use of mobile phones in the study population, including which mobile phone companies are used, and how many SIM cards and handsets each person carries. It will be employed to derive information on population movement from anonymised, aggregated data on mobile phone telephone use, i.e. call detail records (CDR), obtained from mobile phone companies in each country. This will be used for the modelling of population movement, its impact on the distribution of malaria and antimalarial drug resistance, and subsequent prediction of potential routes of spread of malaria and antimalarial drug resistance. As some of this information can be sensitive, during the consent process the patient will be given the option of not providing some or all of this information without needing to provide a reason. For those who do not wish to provide information, this will be documented in the survey form. A duplicate of the sample barcode will be placed on this same form, so the information therein can be matched with the relevant blood spot and its related genetic data, while retaining sample anonymity.

All patients in the study will receive standard care for falciparum malaria including drug therapy according to the national treatment guidelines of their country.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Male or female of any age

• P. falciparum and/or P.Vivax malaria as confirmed by positive rapid diagnostic test or asexual forms of P. falciparum on blood smear microscopy (may be mixed with non-falciparum Plasmodium species)

• Written informed consent by patient, parent/guardian, or legally authorised representative to participate in the study

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Malaria
• Plasmodium Falciparum and Plasmodium Vivax

Locations

Country	Name	City	State
Cambodia	National Centre for Malaria Control, Parasitology and Entomology (CNM)	Phnom Penh
Lao People's Democratic Republic	Center of Malariology, Parasitology and Entomology	Vientiane
Vietnam	Institute of Malariology, Parasitology, and Entomology Quy Nhon	Qui Nhon

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Countries where clinical trial is conducted

Cambodia,  Lao People's Democratic Republic,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual maps and reports on the prevalence of drug resistance-linked genetic mutations in P. falciparum parasites in the Greater Mekong Subregion		up to 12 months
Secondary	Allelic variations associated to drug resistance in P. falciparum at the locations surveyed	By using genotypes produced by high-throughput techniques (sequencing, PCR, mass spectrometry etc.).	up to 12 months
Secondary	Allelic variations associated to drug resistance in P. vivax at the locations surveyed	By using genotypes produced by high-throughput techniques (sequencing, PCR, mass spectrometry etc.).	up to 12 months
Secondary	Genetic differentiation between parasites populations at different locations in the Greater Mekong Subregion	By using population genetic measures such as FST and allele frequencies	up to 12 months
Secondary	Population structure of parasites	By using population genetics and clustering techniques, such as Principal Component Analysis and phylogeny	up to 12 months
Secondary	Gene flow patterns of P. falciparum malaria parasites in the Greater Mekong Subregion		up to 12 months
Secondary	Likely geographic origin of P. falciparum malaria parasites in the Greater Mekong Subregion		up to 12 months