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Epidemiology of Malaria in Ubon Ratchathani, Thailand

Epidemiology of Malaria in Ubon Ratchathani, Thailand: a Case-control Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02991963
Enrollment
660
Registered
2016-12-14
Start date
2016-12-31
Completion date
2018-12-31
Last updated
2017-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidemiology

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

Interventions

OTHERInterview

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

OTHERBlood collection (Dried Blood Spot)

Dried Blood Spot

OTHERBlood Collection (Venous Blood collection)

Venous Blood collection

OTHERBlood Smear

Slide blood smear

Sponsors

Mahidol Oxford Tropical Medicine Research Unit
CollaboratorOTHER
University of Oxford
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Risk factors for Malaria infection2 yearsRisk factors for malaria infection in Ubon Ratchathani Province, Thailand

Secondary

MeasureTime frameDescription
Proportion of malaria infections in Ubon Ratchathani Province2 yearsProportion of malaria infections that are imported in Ubon Ratchathani Province, Thailand
Prevalence of clinical antimalarial drug resistance2 yearsPrevalence of clinical antimalarial drug resistance in cases of P. falciparum malaria in Ubon Ratchathani Province, Thailand
Human movement leading to spread of malaria and antimalarial drug resistance2 years4\. 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 study2 yearsList of antimalarials which patients have recently taken, if any, prior to presentation in order to estimate drug pressure on the parasite population.

Countries

Thailand

Contacts

Primary ContactRichard James Maude, MD
richard@tropmedres.ac+66922871420
Backup ContactVilasinee Yuwaree, Bsc.Pharm
vilasinee@tropmedres.ac+66817017165

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026