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Malaria Genetic Surveillance

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ClinicalTrials.gov Identifier: NCT03384498
Recruitment Status : Recruiting
First Posted : December 27, 2017
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
This study is to determine the prevalence and geographical distribution of antimalarial drug resistance-linked genetic mutations in clinical P. falciparum infections in the Greater Mekong Subregion

Condition or disease
Plasmodium Falciparum

Detailed Description:

This is a prospective observational study of patients with clinical Plasmodium falciparum 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 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 ~60µl 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.


Study Type : Observational
Estimated Enrollment : 30000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic Epidemiology of P. Falciparum Malaria and Associated Antimalarial Drug Resistance
Study Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria




Primary Outcome Measures :
  1. Annual maps and reports on the prevalence of drug resistance-linked genetic mutations in P. falciparum parasites in the Greater Mekong Subregion [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  1. Allelic variations associated to drug resistance in P. falciparum at the locations surveyed [ Time Frame: up to 12 months ]
    By using genotypes produced by high-throughput techniques (sequencing, PCR, mass spectrometry etc.).

  2. Allelic variations associated to drug resistance in P. vivax at the locations surveyed [ Time Frame: up to 12 months ]
    By using genotypes produced by high-throughput techniques (sequencing, PCR, mass spectrometry etc.).

  3. Genetic differentiation between parasites populations at different locations in the Greater Mekong Subregion [ Time Frame: up to 12 months ]
    By using population genetic measures such as FST and allele frequencies

  4. Population structure of parasites [ Time Frame: up to 12 months ]
    By using population genetics and clustering techniques, such as Principal Component Analysis and phylogeny

  5. Gene flow patterns of P. falciparum malaria parasites in the Greater Mekong Subregion [ Time Frame: up to 12 months ]
  6. Likely geographic origin of P. falciparum malaria parasites in the Greater Mekong Subregion [ Time Frame: up to 12 months ]

Biospecimen Retention:   Samples Without DNA
A fingerprick blood sample will be obtained to perform a malaria rapid diagnostic test or blood smear as part of standard care for malaria.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of all ages with P. falciparum malaria who present to participating health facilities in Vietnam, Cambodia, Lao PDR, Thailand and Myanmar are the target study population.
Criteria

Inclusion Criteria:

  • Male or female of any age
  • P. falciparum 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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384498


Contacts
Contact: Olivo Miotto, MD Olivo@tropmedres.ac
Contact: Xin Hui Chan, MD XinHui@tropmedres.ac

Locations
Cambodia
National Centre for Malaria Control, Parasitology and Entomology (CNM) Recruiting
Phnom Penh, Cambodia
Contact: Dr. Huy Rekol         
Lao People's Democratic Republic
Center of Malariology, Parasitology and Entomology Recruiting
Sisattanak District, Vientiane, Lao People's Democratic Republic
Contact: Dr. Bouasy Hongvanthong         
Thailand
Buntharik hospital Recruiting
Ubon Ratchathani, Thailand
Contact: Richard Maude         
Na Chaluai hospital Recruiting
Ubon Ratchathani, Thailand
Vietnam
Institute of Malariology, Parasitology, and Entomology Quy Nhon Recruiting
Qui Nhon, Vietnam
Contact: Dr. Nhien Nguyen Thanh Thuy, MD         
Sponsors and Collaborators
University of Oxford

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03384498     History of Changes
Other Study ID Numbers: BIOINF1602
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by University of Oxford:
Genetic epidemiology
Antimalarial drug resistance

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents