Malaria Survey in the Tak Province Refugee Camps

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Oxford
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01902797
First received: July 10, 2013
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

According to the World Malaria Report, there were significant decreases in the number of P.falciparum (PF) malaria cases worldwide in the past decade. On the Thai-Myanmar border where transmission is low and seasonal and where incidence of Multi-drugs resistant P.falciparum parasites is the highest, the same trend has been observed with a clear decline in malaria episodes and the ratio of P. falciparum/P. vivax (PF/PV.

Economic development, unprecedented financial support, renewed efforts in vector control, a wider use of rapid diagnosic tests (RDTs) for malaria and the deployment of artemisinin based combination treatments (ACT) are the main contributing factors to those successes against malaria.

However the emergence in Cambodia and on the Thai-Myanmar border of P.falciparum isolates that exhibit resistance to artesunate is threatening those gains . This is characterized by a slow parasite clearance rate observed in patients treated with artesunate.

At the same time, recent SMRU surveys along the Thai-Burmese border using a new cutting-edge technology i.e. highly sensitive quantitative Real Time PCR (RT-PCR) able to detect very low parasitaemia (10 parasites per ml), found up to a 3-5 fold increase in the prevalence of malaria compared to what is found with the usual diagnostic tools such as microscopy, RDT or even conventional PCR.

It seems that a large number of asymptomatic carriers with very low parasites counts (a large potential malaria reservoir) go undetected. If confirmed, this might pose the greatest obstacle for malaria elimination in the region and containment of artemisinin resistance.

The purpose of the survey is to further study and understand the epidemiology of malaria in the refugee camp population using cutting-edge technology (RT-PCR) .


Condition Intervention
3 Refugee Camps Under Global Fund Round 10 (GFR10) Project
Other: Questionnaire

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Malaria Survey in the Tak Province Refugee Camps

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Malaria prevalence [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Comparison of malaria prevalence by conventional microscopy and RT-PCR to determine the malaria epidemiology in the population


Secondary Outcome Measures:
  • Determine the percentage of households with at least one long lasting insecticide treated nets (LLIN) or insecticide treated nets (ITNs [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    • percentage of households with at least one long lasting insecticide treated nets (LLIN) or insecticide treated nets (ITNs) per 2 persons

  • Determine the percentage of refugees sleeping under an ITN/LLIN previous night [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Percentage of refugees sleeping under an ITN/LLIN previous night

  • Determine the percentage of refugees who can recall at least 1 key messages on malaria control and containment/elimination [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The percentage of refugees who can recall at least 1 key messages on malaria control and containment/elimination

  • Determine percentage of refugees who stay overnight outside the camp [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The percentage of refugees who stay overnight outside the camp


Estimated Enrollment: 1125
Study Start Date: July 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Household
In each camp, the camp residences are divided into different sections (as clusters for sampling) by camp registration. In the first stage, sections are selected using Population-proportion-to size (PPS) method. In the second stage, households are randomly selected from the household list in each section provided by NGO and local committee. When a household is not responding, a nearest household on the north will be used as replacement. All family members and overnight guests aged above 5 years in the selected household will be invited for venous blood sample (2 ml); for children aged 1-5 years old, the blood sample (100 microL) will be obtained by finger prick; children younger than 1 year old are excluded. The head of household will be invited for a short questionnaire.
Other: Questionnaire
Participants will be invited to complete questionnaires and those who are over 5 year of age will be asked to give blood samples.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Head of household and all family members
  • Overnight guests
  • Age > 12 months
  • Willing to participate in the study and sign informed consent

Exclusion Criteria:

  • All children < 1 year
  • Anyone reported history of abnormal blood coagulation
  • Anyone who does not consent to participate in the survey
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01902797

Contacts
Contact: Francois Nosten, MD PhD +6655545021 francois@tropmedres.ac

Locations
Thailand
Refugee Camps Recruiting
Mae Sot, Tak, Thailand, 63110
Contact: Stephane Proux, PhD    +6655545021    stephane@shoklo-unit.com   
Principal Investigator: Francois Nosten, MD         
Sub-Investigator: Stéphane Proux, PhD         
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Stephane Proux, PhD Shoklo Malaria Research Unit
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01902797     History of Changes
Other Study ID Numbers: SMRU 1303
Study First Received: July 10, 2013
Last Updated: November 29, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
Refugee camps
Household residence
Treated bednets
PCR

ClinicalTrials.gov processed this record on September 18, 2014