Malaria Survey in the Tak Province Refugee Camps

Malaria Clinical Trial

Official title:

Malaria Survey in the Tak Province Refugee Camps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902797
• Other study ID #: SMRU 1303
• Status: Completed
• Phase: N/A
• First received: July 10, 2013
• Last updated: April 27, 2016
• Start date: July 2013
• Est. completion date: December 2013

Study information

• Verified date: April 2016
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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 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) .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 908
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Malaria

Intervention

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.

Locations

Country	Name	City	State
Thailand	Refugee Camps	Mae Sot	Tak

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malaria prevalence	Comparison of malaria prevalence by conventional microscopy and RT-PCR to determine the malaria epidemiology in the population	1 day	No
Secondary	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	1 day	No
Secondary	Determine the percentage of refugees sleeping under an ITN/LLIN previous night	Percentage of refugees sleeping under an ITN/LLIN previous night	1 day	No
Secondary	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	1 day	No
Secondary	Determine percentage of refugees who stay overnight outside the camp	The percentage of refugees who stay overnight outside the camp	1 day	No