EpidemiologyNCT02991963
Epidemiology of Malaria in Ubon Ratchathani, Thailand
An observational study of Epidemiology, run by University of Oxford at 1 site in Thailand.
Trial summary
This is an observational study (case-control study) aiming to identify risk factors for malaria infection in health centers or malaria posts or district hospitals in Buntharik District and Nachalui District, Ubon Ratchathani Province, Thailand. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Epidemiology
- What is being tested?
- Interview, Blood collection (Dried Blood Spot) and Blood Collection (Venous Blood collection)
- How many people
- 660 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2016to Dec 2018
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients self-presenting to health centres or malaria posts or district hospitals in Buntharik District and Nachalui District, Ubon Ratchathani Province, Thailand and requiring a diagnostic test for malaria as determined by the treating clinician will be recruited. Those who are malaria positive will be candidate cases and those who are malaria negative will be candidate controls.
Who may be able to join
- Case (Malaria patient defined by positive RDT or blood smear):
- Patients of ≥ 6 months of age testing positive for malaria of any species as determined by a positive rapid diagnostic test (RDT) or asexual stage parasites on a smear of peripheral blood including individuals with more than one species of Plasmodium.
- Control (Non-malaria patient defined by negative RDT or blood smear):
- Patients > 6 months of age requiring a diagnostic test for malaria but testing negative for malaria by rapid diagnostic test (RDT) or asexual stage parasites on a smear of peripheral blood. Controls will be age and gender matched to individual cases at each study site (details below).
Who cannot join
- Not willing to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Buntharik Hospital
Ubon Ratchathani, Changwat Ubon Ratchathani, 34230
Tanong Kamsri, Doctor, drtanong@yahoo.com
Vilasinee Yuwaree, +66817017165, vilasinee@tropmedres.ac
About this study
Official title: Epidemiology of Malaria in Ubon Ratchathani, Thailand: a Case-control Study
This is an observational study (case-control study) aiming to identify risk factors for malaria infection in health centers or malaria posts or district hospitals in Buntharik District and Nachalui District, Ubon Ratchathani Province, Thailand.
This study expects to recruit 330 cases (malaria positive) and 330 control (negative cases) subject. One-to-one matching of cases (malaria positive) and controls (malaria negative) will be done at each study site.
Read more
CASE (Malaria positive) subject will go through the following;
- Enrollment visit (Day 0) 1.1 Blood collection of three dried blood spots, and malaria slide. In district hospitals in individuals >14 kg: additional 10ml venous blood will be collected. 1.2 A survey questionnaire which includes patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones will be administered.
- Follow up visits (if fever plus Day 42 (+/-3))
2.1 Blood collection of three dried blood spots and malaria slide. In district hospitals: additional 0.5ml venous blood will be collected.
2.2 Short survey questionnaire including questions on symptoms, travel and possible risk behaviors since enrollment will be administered.
CONTROL (Malaria negative) subject will go through the following;
- Enrollment visit (Day 0) 1.1 Blood collection to confirm negative malaria slide. In district hospitals: additional 0.5ml venous blood will be collected. 1.2 A survey questionnaire including patient demographics, information on any recent malaria treatment they may have taken, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones will be administered.
- Follow up visit: No follow up visit
Read the detailed description
Study sites and enrollment:
Patients self-presenting to (1) health centres or(2) malaria posts or (3) district hospitals in Buntharik District and Nachalui District, Ubon Ratchathani Province, Thailand and requiring a diagnostic test for malaria as determined by the treating clinician will be recruited. Those who are malaria positive will be candidate cases and those who are malaria negative will be candidate controls.
One-to-one matching of cases and controls will be done at each study site. One control will be matched to each case. The matching criteria will be the next malaria negative patient to attend the study site of the same gender and age+/-5 years as an enrolled malaria positive case.
Study procedure:
CASE (Malaria patient defined by positive RDT or blood smear)
Upon enrollment, the below study procedures will be followed;
- Blood samples consisting of:
- Three dried blood spots
- A microscopy slide
- In the district hospitals only, 10 ml of venous blood will be taken from the positive for malaria patient.
- A survey include patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phone will be administered to each patient.
CONTROL (Non-malaria patient defined by negative RDT or blood smear)
Upon enrollment, for those negative for malaria, the below study procedures will be follows;
- Blood samples consisting of:
- Blood smear
- In the district hospitals only, 0.5 ml of venous blood will also be collected.
- A survey include patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phone swill be administered to each patient.
CASE: Follow-up
- If patients develop a fever after the end of antimalarial treatment and within 42 days after enrollment, they will be asked to return for follow-up as soon as possible on one occasion and then again at 42 (+/-3) days.
- If they do not develop fever within 42 days after enrollment, they will be asked to return for follow up at 42 (+/-3) days.
At the follow-up visit, blood will be taken to test for malaria by microscopy, three dried blood spots will be taken and a short survey administered including questions on symptoms, travel and possible risk behaviors since enrollment.
*In the district hospitals only, 1.5ml of venous blood will be taken
CONTROL: No follow up
- Conditions
- Epidemiology
- Being tested
- Interview, Blood collection (Dried Blood Spot), Blood Collection (Venous Blood collection), Blood Smear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
A survey will be included patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones
Blood collection (Dried Blood Spot)Other
Dried Blood Spot
Blood Collection (Venous Blood collection)Other
Venous Blood collection
Blood SmearOther
Slide blood smear
| Study group | Role | What they receive |
|---|---|---|
| Case | Malaria patient defined by positive RDT or blood smear Receives: Other: Interview; Other: Blood collection (Dried Blood Spot); Other: Blood Collection (Venous Blood collection); Other: Blood Smear | |
| Control | Non-malaria patient defined by negative RDT or blood smear Receives: Other: Interview; Other: Blood Collection (Venous Blood collection); Other: Blood Smear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors for Malaria infection
Risk factors for malaria infection in Ubon Ratchathani Province, Thailand
Measured: 2 years
Secondary outcomes (4)
Proportion of malaria infections in Ubon Ratchathani Province
Proportion of malaria infections that are imported in Ubon Ratchathani Province, Thailand
Measured: 2 years
Prevalence of clinical antimalarial drug resistance
Prevalence of clinical antimalarial drug resistance in cases of P. falciparum malaria in Ubon Ratchathani Province, Thailand
Measured: 2 years
Human movement leading to spread of malaria and antimalarial drug resistance
- Estimates of the potential for spread of malaria and antimalarial drug resistance from Ubon Ratchathani Province, Thailand through human movement to other locations.
Measured: 2 years
Measure antimalarial drug in blood prior to participate in the study
List of antimalarials which patients have recently taken, if any, prior to presentation in order to estimate drug pressure on the parasite population.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpidemiologyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991963
- Sponsor's protocol ID
- EPI1601
- Status last verified
- Jan 2017
- First submitted
- 9 Dec 2016
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: According to Mahidol-Oxford Tropical Medicine Research Unit policy
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Malaria in Ubon Ratchathani, Thailand: a Case-control Study
- ClinicalTrials.gov ID
- NCT02991963
- Acronym / sponsor ID
- EPI1601
- Conditions
- Epidemiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 14 Dec 2016 (estimated)
- 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 is an observational study (case-control study) aiming to identify risk factors for malaria infection in health centers or malaria posts or district hospitals in Buntharik District and Nachalui District, Ubon Ratchathani Province, Thailand.
This study expects to recruit 330 cases (malaria positive) and 330 control (negative cases) subject. One-to-one matching of cases (malaria positive) and controls (malaria negative) will be done at each study site.
CASE (Malaria positive) subject will go through the following;
- Enrollment visit (Day 0) 1.1 Blood collection of three dried blood spots, and malaria slide. In district hospitals in individuals >14 kg: additional 10ml venous blood will be collected. 1.2 A survey questionnaire which includes patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones will be administered.
- Follow up visits (if fever plus Day 42 (+/-3))
2.1 Blood collection of three dried blood spots and malaria slide. In district hospitals: additional 0.5ml venous blood will be collected.
2.2 Short survey questionnaire including questions on symptoms, travel and possible risk behaviors since enrollment will be administered.
CONTROL (Malaria negative) subject will go through the following;
- Enrollment visit (Day 0) 1.1 Blood collection to confirm negative malaria slide. In district hospitals: additional 0.5ml venous blood will be collected. 1.2 A survey questionnaire including patient demographics, information on any recent malaria treatment they may have taken, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones will be administered.
- Follow up visit: No follow up visit
Detailed description
Study sites and enrollment:
Patients self-presenting to (1) health centres or(2) malaria posts or (3) district hospitals in Buntharik District and Nachalui District, Ubon Ratchathani Province, Thailand and requiring a diagnostic test for malaria as determined by the treating clinician will be recruited. Those who are malaria positive will be candidate cases and those who are malaria negative will be candidate controls.
One-to-one matching of cases and controls will be done at each study site. One control will be matched to each case. The matching criteria will be the next malaria negative patient to attend the study site of the same gender and age+/-5 years as an enrolled malaria positive case.
Study procedure:
CASE (Malaria patient defined by positive RDT or blood smear)
Upon enrollment, the below study procedures will be followed;
- Blood samples consisting of:
- Three dried blood spots
- A microscopy slide
- In the district hospitals only, 10 ml of venous blood will be taken from the positive for malaria patient.
- A survey include patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phone will be administered to each patient.
CONTROL (Non-malaria patient defined by negative RDT or blood smear)
Upon enrollment, for those negative for malaria, the below study procedures will be follows;
- Blood samples consisting of:
- Blood smear
- In the district hospitals only, 0.5 ml of venous blood will also be collected.
- A survey include patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phone swill be administered to each patient.
CASE: Follow-up
- If patients develop a fever after the end of antimalarial treatment and within 42 days after enrollment, they will be asked to return for follow-up as soon as possible on one occasion and then again at 42 (+/-3) days.
- If they do not develop fever within 42 days after enrollment, they will be asked to return for follow up at 42 (+/-3) days.
At the follow-up visit, blood will be taken to test for malaria by microscopy, three dried blood spots will be taken and a short survey administered including questions on symptoms, travel and possible risk behaviors since enrollment.
*In the district hospitals only, 1.5ml of venous blood will be taken
CONTROL: No follow up
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: Interview, Other: Blood collection (Dried Blood Spot), Other: Blood Collection (Venous Blood collection), Other: Blood SmearMalaria patient defined by positive RDT or blood smear |
| Control | – | Other: Interview, Other: Blood Collection (Venous Blood collection), Other: Blood SmearNon-malaria patient defined by negative RDT or blood smear |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients self-presenting to health centres or malaria posts or district hospitals in Buntharik District and Nachalui District, Ubon Ratchathani Province, Thailand and requiring a diagnostic test for malaria as determined by the treating clinician will be recruited. Those who are malaria positive will be candidate cases and those who are malaria negative will be candidate controls.
Key inclusion criteria (4 listed)
- Case (Malaria patient defined by positive RDT or blood smear):
- Patients of ≥ 6 months of age testing positive for malaria of any species as determined by a positive rapid diagnostic test (RDT) or asexual stage parasites on a smear of peripheral blood including individuals with more than one species of Plasmodium.
- Patients > 6 months of age requiring a diagnostic test for malaria but testing negative for malaria by rapid diagnostic test (RDT) or asexual stage parasites on a smear of peripheral blood. Controls will be age and gender matched to individual cases at each study site (details below).
Key exclusion criteria (1 listed)
- Not willing to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewA survey will be included patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones | Other | Case, Control |
| Blood collection (Dried Blood Spot)Dried Blood Spot | Other | Case |
| Blood Collection (Venous Blood collection)Venous Blood collection | Other | Case, Control |
| Blood SmearSlide blood smear | Other | Case, Control |
Primary outcome
Risk factors for Malaria infection
Time frame: 2 years
Risk factors for malaria infection in Ubon Ratchathani Province, Thailand
4 secondary outcomes
Proportion of malaria infections in Ubon Ratchathani Province
Time frame: 2 years
Prevalence of clinical antimalarial drug resistance
Time frame: 2 years
Human movement leading to spread of malaria and antimalarial drug resistance
Time frame: 2 years
Measure antimalarial drug in blood prior to participate in the study
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- Individual participant dataSharing planned: Yes. According to Mahidol-Oxford Tropical Medicine Research Unit policy
Related trials for Epidemiology
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Not yet recruitingObservational study
The GEIR (Grupo español de Ictus Retina) Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion, Central Retinal Artery Occlusion
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
RecruitingObservational study
Fibrous Dysplasia: An Epidemiological and Correlational Evaluation of Multimodal Data
Fibrous Dysplasia, Fibrous Dysplasia of Bone
RecruitingObservational study
Children and Adults With Chordoma
Chordoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidemiology, run by University of Oxford at 1 site in Thailand.
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 4 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 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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 Richard James Maude, MD (+66922871420, richard@tropmedres.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors for Malaria infection (time frame: 2 years). 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 20 Jan 2017.