Plasmodium Falciparum and Plasmodium VivaxNCT03384498
Malaria Genetic Surveillance
An observational study of Plasmodium Falciparum and Plasmodium Vivax, run by University of Oxford at 3 sites in 3 countries.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Plasmodium Falciparum and Plasmodium Vivax
- How many people
- 30,000 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2016to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of all ages with P. falciparum and/or P.Vivax malaria who present to participating health facilities in Vietnam, Cambodia, Lao PDR, Thailand and Myanmar are the target study population.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
3 sites in 3 countries.
Olivo Miotto, MD contact
3 sites in 3 countries
Cambodia1 site, 1 recruiting
- Recruiting
National Centre for Malaria Control, Parasitology and Entomology (CNM)
Phnom Penh
Dr. Siv Sovannaroth
Laos1 site, 1 recruiting
- Recruiting
Center of Malariology, Parasitology and Entomology
Vientiane
Dr. Viengxay Vanisaveth
Vietnam1 site, 1 recruiting
- Recruiting
Institute of Malariology, Parasitology, and Entomology Quy Nhon
Qui Nhon
Dr. Nhien Nguyen Thanh Thuy, MD
About this study
Official title: Genetic Epidemiology of Malaria and Associated Antimalarial Drug Resistance
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
Read the detailed 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.
- Keywords
- Genetic epidemiology, Antimalarial drug resistance
- Medical subject headings
- Malaria, Falciparum, Malaria, Vivax
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual maps and reports on the prevalence of drug resistance-linked genetic mutations in P. falciparum parasites in the Greater Mekong Subregion
Measured: up to 12 months
Secondary outcomes (6)
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.).
Measured: up to 12 months
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.).
Measured: up to 12 months
Genetic differentiation between parasites populations at different locations in the Greater Mekong Subregion
By using population genetic measures such as FST and allele frequencies
Measured: up to 12 months
Population structure of parasites
By using population genetics and clustering techniques, such as Principal Component Analysis and phylogeny
Measured: up to 12 months
Gene flow patterns of P. falciparum malaria parasites in the Greater Mekong Subregion
Measured: up to 12 months
Likely geographic origin of P. falciparum malaria parasites in the Greater Mekong Subregion
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study startOct 2016
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium Falciparum and Plasmodium VivaxStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384498
- Sponsor's protocol ID
- BIOINF1602
- Status last verified
- Mar 2022
- First submitted
- 18 Aug 2016
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Epidemiology of Malaria and Associated Antimalarial Drug Resistance
- ClinicalTrials.gov ID
- NCT03384498
- Acronym / sponsor ID
- BIOINF1602
- Keywords
- Genetic epidemiology, Antimalarial drug resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of all ages with P. falciparum and/or P.Vivax malaria who present to participating health facilities in Vietnam, Cambodia, Lao PDR, Thailand and Myanmar are the target study population.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Allelic variations associated to drug resistance in P. falciparum at the locations surveyed
Time frame: up to 12 months
Allelic variations associated to drug resistance in P. vivax at the locations surveyed
Time frame: up to 12 months
Genetic differentiation between parasites populations at different locations in the Greater Mekong Subregion
Time frame: up to 12 months
Population structure of parasites
Time frame: up to 12 months
Gene flow patterns of P. falciparum malaria parasites in the Greater Mekong Subregion
Time frame: up to 12 months
Likely geographic origin of P. falciparum malaria parasites in the Greater Mekong Subregion
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Individual participant dataSharing planned: Yes
Related trials for Plasmodium Falciparum and Plasmodium Vivax
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Ethiopian Antimalarial Therapeutic Efficacy Study 2026
Plasmodium Vivax Malaria Without Complication, Plasmodium Falciparum Malaria (Uncomplicated)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivo Miotto, MD contact
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasmodium Falciparum and Plasmodium Vivax, run by University of Oxford at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Cambodia, Laos, Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivo Miotto, MD (Olivo@tropmedres.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.