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Epidemiology of Malaria in Ubon Ratchathani, Thailand

19 januari 2017 bijgewerkt door: University of Oxford

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

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Studietype

Observationeel

Inschrijving (Verwacht)

660

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Thailand
    • Ubon Rachatani
      • Ubon Ratchathani, Ubon Rachatani, Thailand, 34230
        • Werving
        • Buntharik Hospital
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Tanong Kamsri, doctor

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

6 maanden en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Case-control
  • Tijdsperspectieven: Prospectief

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Case
Malaria patient defined by positive RDT or blood smear
Ander: 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
Ander: Blood collection (Dried Blood Spot)
Dried Blood Spot
Ander: Blood Collection (Venous Blood collection)
Venous Blood collection
Ander: Blood Smear
Slide blood smear
Control
Non-malaria patient defined by negative RDT or blood smear
Ander: 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
Ander: Blood Collection (Venous Blood collection)
Venous Blood collection
Ander: Blood Smear
Slide blood smear

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Risk factors for Malaria infection
Tijdsspanne: 2 years
Risk factors for malaria infection in Ubon Ratchathani Province, Thailand
2 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of malaria infections in Ubon Ratchathani Province
Tijdsspanne: 2 years
Proportion of malaria infections that are imported in Ubon Ratchathani Province, Thailand
2 years
Prevalence of clinical antimalarial drug resistance
Tijdsspanne: 2 years
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
Tijdsspanne: 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.
2 years
Measure antimalarial drug in blood prior to participate in the study
Tijdsspanne: 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.
2 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Oxford

Medewerkers

Mahidol Oxford Tropical Medicine Research Unit

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 december 2016

Primaire voltooiing (Verwacht)

1 december 2018

Studie voltooiing (Verwacht)

1 december 2018

Studieregistratiedata

Eerst ingediend

9 december 2016

Eerst ingediend dat voldeed aan de QC-criteria

13 december 2016

Eerst geplaatst (Schatting)

14 december 2016

Updates van studierecords

Laatste update geplaatst (Schatting)

20 januari 2017

Laatste update ingediend die voldeed aan QC-criteria

19 januari 2017

Laatst geverifieerd

1 januari 2017

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • EPI1601

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Ja

Beschrijving IPD-plan

According to Mahidol-Oxford Tropical Medicine Research Unit policy

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