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Malaria Survey in the Tak Province Refugee Camps

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01902797
First Posted: July 18, 2013
Last Update Posted: April 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Oxford
  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
Malaria Other: Questionnaire

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    • 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 ]
    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 ]
    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 ]
    The percentage of refugees who stay overnight outside the camp


Enrollment: 908
Study Start Date: July 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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.

  Hide Detailed Description

Detailed Description:

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) .

The necessity of research in Humans With the double mission of malaria elimination and artemisinin-resistance containment, there are intensive malaria activities currently implemented in the refugee camps in the Tak province (a province in Thailand that is on the Thai-Burmese border). The malaria risk among the refugee camp is higher than the Thai residences inside Thailand.

To avoid resource wastage, it is thus essential to conduct a simple questionnaire to understand the current situation of malaria prevention in the camps, especially information regarding the mosquito net ownership and usage (mosquito net distribution has been a major malaria prevention activity among the NGOs in the camps).

PCR method is being used more and more in recent year due to its sensitivity compared to slide reading. PCR is considered being able to capture more cases with sub-microscopic infection. However, the current PCR methods conventionally used in malaria survey usually use finger prick to obtain only few microliters of capillary blood , the detectable level of parasitaemia is therefore limited due to minimal amount of blood from which Plasmodium DNA can be extracted. Thus the RT-PCR method proposed here using 2ml venous blood well compensates these shortcomings.

The comparison of test results of conventional microscopy (currently still as the universal golden standard in the clinics) and RT-PCR will not only enable detection of both symptomatic and asymptomatic malaria cases but help define the epidemiology apart from our conventional understanding of malaria.

Thus this study is necessary and is strategically important for the next roadmap development of malaria elimination and resistance containment.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902797


Locations
Thailand
Refugee Camps
Mae Sot, Tak, Thailand, 63110
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Stephane Proux, PhD Shoklo Malaria Research Unit
  More Information

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01902797     History of Changes
Other Study ID Numbers: SMRU 1303
First Submitted: July 10, 2013
First Posted: July 18, 2013
Last Update Posted: April 28, 2016
Last Verified: April 2016

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

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases