Epidemiology of Malaria in Ubon Ratchathani, Thailand

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.

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

Study Overview

• Status: Unknown
• Conditions: Epidemiology
• Intervention / Treatment: Other: Interview; Other: Blood collection (Dried Blood Spot); Other: Blood Collection (Venous Blood collection); Other: Blood Smear

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;

1. 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.
2. 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;

1. Blood samples consisting of:

   • Blood smear
   • In the district hospitals only, 0.5 ml of venous blood will also be collected.
2. 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 Type: Observational
• Enrollment (Anticipated): 660

Contacts and Locations

• Study Contact: Name: Richard James Maude, MD; Phone Number: +66922871420; Email: richard@tropmedres.ac
• Study Contact Backup: Name: Vilasinee Yuwaree, Bsc.Pharm; Phone Number: +66817017165; Email: vilasinee@tropmedres.ac

Study Locations

• Thailand
  • Ubon Rachatani
    • Ubon Ratchathani, Ubon Rachatani, Thailand, 34230
      • Recruiting
      • Buntharik Hospital
      • Contact: Tanong Kamsri, Doctor; Email: drtanong@yahoo.com
      • Contact: Vilasinee Yuwaree; Phone Number: +66817017165; Email: vilasinee@tropmedres.ac
      • Principal Investigator: Tanong Kamsri, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors for Malaria infection	Risk factors for malaria infection in Ubon Ratchathani Province, Thailand	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of malaria infections in Ubon Ratchathani Province	Proportion of malaria infections that are imported in Ubon Ratchathani Province, Thailand	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	2 years
Human movement leading to spread of malaria and antimalarial drug resistance	4. Estimates of the potential for spread of malaria and antimalarial drug resistance from Ubon Ratchathani Province, Thailand through human movement to other locations.	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.	2 years

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Mahidol Oxford Tropical Medicine Research Unit

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: December 9, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (Estimate): December 14, 2016

Study Record Updates

• Last Update Posted (Estimate): January 20, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria
• Other Study ID Numbers: EPI1601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: According to Mahidol-Oxford Tropical Medicine Research Unit policy