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MalariaNCT01902797

Malaria Survey in the Tak Province Refugee Camps

A study testing Questionnaire in people with Malaria, run by University of Oxford at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 12 months and olderHealthy volunteers can take part
Conditions the study is for
Malaria
What is being tested?
Questionnaire
Could I receive a placebo?
No, everyone receives an active treatment
How many people
908 participants
Where
1 siteThailand
Study dates
Jul 2013to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 months and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • All children < 1 year
  • Anyone reported history of abnormal blood coagulation
  • Anyone who does not consent to participate in the survey

Trial locations and contacts

1 site in 1 country.

Thailand1 site
  • Refugee Camps

    Mae Sot, Changwat Tak, 63110

Other trials in Thailand

About this study

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.

Read more

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) .

Read the 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.

Conditions
Malaria
Being tested
Questionnaire
Keywords
Refugee camps, Household residence, Treated bednets, PCR
Medical subject headings
Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireOther

    Participants will be invited to complete questionnaires and those who are over 5 year of age will be asked to give blood samples.

Study groups in NCT01902797
Study groupRoleWhat they receive
HouseholdExperimentalIn 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.
Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Malaria prevalence

    Comparison of malaria prevalence by conventional microscopy and RT-PCR to determine the malaria epidemiology in the population

    Measured: 1 day

Secondary outcomes (4)
  1. Determine the percentage of households with at least one long lasting insecticide treated nets (LLIN) or insecticide treated nets (ITNs

    • percentage of households with at least one long lasting insecticide treated nets (LLIN) or insecticide treated nets (ITNs) per 2 persons

    Measured: 1 day

  2. Determine the percentage of refugees sleeping under an ITN/LLIN previous night

    Percentage of refugees sleeping under an ITN/LLIN previous night

    Measured: 1 day

  3. Determine the percentage of refugees who can recall at least 1 key messages on malaria control and containment/elimination

    The percentage of refugees who can recall at least 1 key messages on malaria control and containment/elimination

    Measured: 1 day

  4. Determine percentage of refugees who stay overnight outside the camp

    The percentage of refugees who stay overnight outside the camp

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
908 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01902797
Sponsor's protocol ID
SMRU 1303
Status last verified
Apr 2016
First submitted
10 Jul 2013
Last updated
28 Apr 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Questionnaire in people with Malaria, run by University of Oxford at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Malaria prevalence (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016.

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