NCT01902797

Brief 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) .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
908

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

5 months

First QC Date

July 10, 2013

Last Update Submit

April 27, 2016

Conditions

Keywords

Refugee campsHousehold residenceTreated bednetsPCR

Outcome Measures

Primary Outcomes (1)

  • Malaria prevalence

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

    1 day

Secondary Outcomes (4)

  • Determine the percentage of households with at least one long lasting insecticide treated nets (LLIN) or insecticide treated nets (ITNs

    1 day

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

    1 day

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

    1 day

  • Determine percentage of refugees who stay overnight outside the camp

    1 day

Study Arms (1)

Household

EXPERIMENTAL

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

Interventions

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

Household

Eligibility Criteria

Age12 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Refugee Camps

Mae Sot, Changwat Tak, 63110, Thailand

Location

MeSH Terms

Conditions

Malaria

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Stephane Proux, PhD

    Shoklo Malaria Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 18, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 28, 2016

Record last verified: 2016-04

Locations