Epidemiology of Malaria in Ubon Ratchathani, Thailand

• Conditions: Epidemiology
• Interventions: Other: Interview; Other: Blood Collection (Venous Blood collection); Other: Blood collection (Dried Blood Spot); Other: Blood Smear

• Registration Number: NCT02991963
• Lead Sponsor: 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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-09
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-14
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 660

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).

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Exclusion Criteria

Not willing to provide written informed consent.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	Blood Smear	Malaria patient defined by positive RDT or blood smear
Case	Interview	Malaria patient defined by positive RDT or blood smear
Control	Blood Collection (Venous Blood collection)	Non-malaria patient defined by negative RDT or blood smear
Control	Interview	Non-malaria patient defined by negative RDT or blood smear
Case	Blood Collection (Venous Blood collection)	Malaria patient defined by positive RDT or blood smear
Case	Blood collection (Dried Blood Spot)	Malaria patient defined by positive RDT or blood smear
Control	Blood Smear	Non-malaria patient defined by negative RDT or blood smear

Primary Outcome Measures

Name	Time	Method
Risk factors for Malaria infection	2 years	Risk factors for malaria infection in Ubon Ratchathani Province, Thailand

Secondary Outcome Measures

Name	Time	Method
Human movement leading to spread of malaria and antimalarial drug resistance	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.
Measure antimalarial drug in blood prior to participate in the study	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.
Proportion of malaria infections in Ubon Ratchathani Province	2 years	Proportion of malaria infections that are imported in Ubon Ratchathani Province, Thailand
Prevalence of clinical antimalarial drug resistance	2 years	Prevalence of clinical antimalarial drug resistance in cases of P. falciparum malaria in Ubon Ratchathani Province, Thailand

Trial Locations

Locations (1)

Buntharik Hospital; 🇹🇭 Ubon Ratchathani, Ubon Rachatani, Thailand