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Epidemiology of Malaria in Ubon Ratchathani, Thailand

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ClinicalTrials.gov Identifier: NCT02991963
Recruitment Status : Unknown
Verified January 2017 by University of Oxford.
Recruitment status was:  Recruiting
First Posted : December 14, 2016
Last Update Posted : January 20, 2017
Sponsor:
Collaborator:
Mahidol Oxford Tropical Medicine Research Unit
Information provided by (Responsible Party):
University of Oxford

Brief 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.

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;

  1. 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.

  2. 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;

  1. 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.

  2. Follow up visit: No follow up visit

Condition or disease Intervention/treatment
Epidemiology Other: Interview Other: Blood collection (Dried Blood Spot) Other: Blood Collection (Venous Blood collection) Other: Blood Smear

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Study Type : Observational
Estimated Enrollment : 660 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Epidemiology of Malaria in Ubon Ratchathani, Thailand: a Case-control Study
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Group/Cohort Intervention/treatment
Case
Malaria patient defined by positive RDT or blood smear
Other: Interview
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

Other: Blood collection (Dried Blood Spot)
Dried Blood Spot

Other: Blood Collection (Venous Blood collection)
Venous Blood collection

Other: Blood Smear
Slide blood smear

Control
Non-malaria patient defined by negative RDT or blood smear
Other: Interview
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

Other: Blood Collection (Venous Blood collection)
Venous Blood collection

Other: Blood Smear
Slide blood smear




Primary Outcome Measures :
  1. Risk factors for Malaria infection [ Time Frame: 2 years ]
    Risk factors for malaria infection in Ubon Ratchathani Province, Thailand


Secondary Outcome Measures :
  1. Proportion of malaria infections in Ubon Ratchathani Province [ Time Frame: 2 years ]
    Proportion of malaria infections that are imported in Ubon Ratchathani Province, Thailand

  2. Prevalence of clinical antimalarial drug resistance [ Time Frame: 2 years ]
    Prevalence of clinical antimalarial drug resistance in cases of P. falciparum malaria in Ubon Ratchathani Province, Thailand

  3. Human movement leading to spread of malaria and antimalarial drug resistance [ Time Frame: 2 years ]
    4. Estimates of the potential for spread of malaria and antimalarial drug resistance from Ubon Ratchathani Province, Thailand through human movement to other locations.

  4. Measure antimalarial drug in blood prior to participate in the study [ Time Frame: 2 years ]
    List of antimalarials which patients have recently taken, if any, prior to presentation in order to estimate drug pressure on the parasite population.


Biospecimen Retention:   Samples Without DNA
  1. Dried Blood Spot

    • To extract information on a broad variety of genetic variations.
    • To analyse for P. falciparum multi-drug resistance gene (MDR) copy number as a marker of mefloquine resistance, as well as for merozoite surface protein (MSP), glutamate rich protein (GLURP) and other markers to compare with follow-up samples to identify relapses and recrudescences.
  2. Venous Blood for parasite culture and in vitro drug sensitivity, cryopreservation of parasites, malaria immunological tests, antimalarial pharmacokinetics, ultrasensitive Plasmodium PCR and whole genome sequencing


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

- 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).

Exclusion Criteria:

Not willing to provide written informed consent.


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): NCT02991963


Contacts
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Contact: Richard James Maude, MD +66922871420 richard@tropmedres.ac
Contact: Vilasinee Yuwaree, Bsc.Pharm +66817017165 vilasinee@tropmedres.ac

Locations
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Thailand
Buntharik Hospital Recruiting
Ubon Ratchathani, Ubon Rachatani, Thailand, 34230
Contact: Tanong Kamsri, Doctor       drtanong@yahoo.com   
Contact: Vilasinee Yuwaree    +66817017165    vilasinee@tropmedres.ac   
Principal Investigator: Tanong Kamsri, doctor         
Sponsors and Collaborators
University of Oxford
Mahidol Oxford Tropical Medicine Research Unit
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02991963    
Other Study ID Numbers: EPI1601
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to Mahidol-Oxford Tropical Medicine Research Unit policy
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases