Malaria Genetic Surveillance in Cambodia

May 17, 2022 updated by: University of Oxford

Integrating Genetic Epidemiology as an Intensified Surveillance Tool Into the National Centre for Parasitology, Entomology and Malaria Control of Cambodia

This study is to determine the prevalence and geographical distribution of antimalarial drug resistance-linked genetic mutations in clinical P. falciparum infections in Cambodia

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This is a prospective observational study of patients with clinical Plasmodium falciparum infection using parasite DNA from point-of-care fingerprick dried blood spot samples as well as a short survey on patient demographics, employment, travel, and mobile phone use to study P. falciparum parasite genotypes, population characteristics, and gene flow patterns.

On inclusion in the study and before standard treatment is administered, dried blood spots (DBS) will be obtained through fingerprick blood sampling from patients, with three blood spots on one piece of filter paper being obtained from each patient. Each blood spot will contain ~20µl of blood, for a total of ~60µl of blood being collected from each patient for the study.

In order to have a greater understanding of the possible sites of malaria transmission and to relate genetic diversity to geographic location, patients or their parents/guardians will also be asked a short set of questions on demographics, their places of residence and work, recent mobile phone use, and their history of travel in the last 2 months. As some of this information can be sensitive, during the consent process the patient will be given the option of not providing some or all of this information without needing to provide a reason. This is explained on the patient information sheet. For those who do not want to provide information, this will be documented in the survey form. A duplicate of the sample barcode will be placed on this same form, so the information therein can be matched with the relevant blood spot and its related genetic data, while retaining sample anonymity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
185

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients > 6 months of age with P. falciparum malaria who present to village malaria workers and health centres in Stung Treng and Ratanakiri provinces in Cambodia are the target study population. 2014 data suggest this could amount to up to 7,000 patients per year. All study participants must satisfy the applicable inclusion and exclusion criteria

Description

Inclusion Criteria:

  • Male or female >6 months of age
  • P. falciparum malaria as confirmed by positive rapid diagnostic test or asexual forms of P. falciparum on blood smear microscopy (may be mixed with non-falciparum Plasmodium species)
  • Written informed consent by patient, parent/guardian, or legally authorised representative to participate in the study

Exclusion Criteria:

• None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Annual maps and reports on the prevalence of drug resistance-linked genetic mutations in P. falciparum parasites in Cambodia
Time Frame: up to 12 months
up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Population structure of P.falciparum parasites
Time Frame: up to 12 months
By using population genetics and clustering techniques, such as Principal Component Analysis and phylogeny
up to 12 months
Gene flow patterns of P. falciparum malaria parasites in Cambodia
Time Frame: up to 12 months
up to 12 months
Likely geographic origin of P. falciparum malaria parasites in Cambodia
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oxford

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mahidol Oxford Tropical Medicine Research Unit
National Centre for Parasitology, Entomology and Malaria Control, Cambodia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BIOINF1601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised data recorded in the CRFs will be shared via open access online repositories as per the requirements of the journal in which the results of the study are published.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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