Epidemiology of Malaria in Ubon Ratchathani, Thailand

NCT02991963 | Unknown

• 1 other identifier: EPI1601
• Study Type: observational
• Target: 660
• Locations: 1 country
• Sites: 1

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. 1.Enrollment visit (Day 0)
2. 2.Follow up visits (if fever plus Day 42 (+/-3))
3. 3.Enrollment visit (Day 0)
4. 4.Follow up visit: No follow up visit

Conditions

Epidemiology

Outcome Measures

Primary Outcomes (1)

• Risk factors for Malaria infection

  Risk factors for malaria infection in Ubon Ratchathani Province, Thailand

  2 years

Secondary Outcomes (4)

• Proportion of malaria infections in Ubon Ratchathani Province

  2 years

• Prevalence of clinical antimalarial drug resistance

  2 years

• Human movement leading to spread of malaria and antimalarial drug resistance

  2 years

• Measure antimalarial drug in blood prior to participate in the study

  2 years

Study Arms (2)

Case

Malaria patient defined by positive RDT or blood smear

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

Other: Interview; Other: Blood Collection (Venous Blood collection); Other: Blood Smear

Interventions

Interview OTHER

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

Case; Control

Blood collection (Dried Blood Spot) OTHER

Dried Blood Spot

Case

Blood Collection (Venous Blood collection) OTHER

Venous Blood collection

Case; Control

Blood Smear OTHER

Slide blood smear

Case; Control

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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).

You may not qualify if:

• Not willing to provide written informed consent.

Sponsors & Collaborators

• University of Oxford: lead
• Mahidol Oxford Tropical Medicine Research Unit: collaborator

Study Sites (1)

Buntharik Hospital

Ubon Ratchathani, Ubon Rachatani, 34230, Thailand

RECRUITING

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

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Richard James Maude, MD

CONTACT

+66922871420; richard@tropmedres.ac

Vilasinee Yuwaree, Bsc.Pharm

CONTACT

+66817017165; vilasinee@tropmedres.ac

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 14, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 20, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

TH (1)