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Epidemiology of Malaria in Ubon Ratchathani, Thailand

19 januari 2017 uppdaterad av: 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

Studieöversikt

Detaljerad beskrivning

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

Studietyp

Observationell

Inskrivning (Förväntat)

660

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Ubon Rachatani
      • Ubon Ratchathani, Ubon Rachatani, Thailand, 34230
        • Rekrytering
        • Buntharik Hospital
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Tanong Kamsri, doctor

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

6 månader och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Case
Malaria patient defined by positive RDT or blood smear
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
Dried Blood Spot
Venous Blood collection
Slide blood smear
Control
Non-malaria patient defined by negative RDT or blood smear
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
Venous Blood collection
Slide blood smear

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Risk factors for Malaria infection
Tidsram: 2 years
Risk factors for malaria infection in Ubon Ratchathani Province, Thailand
2 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of malaria infections in Ubon Ratchathani Province
Tidsram: 2 years
Proportion of malaria infections that are imported in Ubon Ratchathani Province, Thailand
2 years
Prevalence of clinical antimalarial drug resistance
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 december 2016

Primärt slutförande (Förväntat)

1 december 2018

Avslutad studie (Förväntat)

1 december 2018

Studieregistreringsdatum

Först inskickad

9 december 2016

Först inskickad som uppfyllde QC-kriterierna

13 december 2016

Första postat (Uppskatta)

14 december 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

20 januari 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 januari 2017

Senast verifierad

1 januari 2017

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • EPI1601

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Ja

IPD-planbeskrivning

According to Mahidol-Oxford Tropical Medicine Research Unit policy

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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