Evaluation of Different G6PD Testing Platforms

October 27, 2014 updated by: PATH

Evaluation of a Point-of-care G6PD Diagnostic Test

In this study the investigators propose to evaluate the performance of several G6PD testing platforms.

Study Overview

Status

Completed

Conditions

Detailed Description

In this study we propose to evaluate the performance of several G6PD testing platforms. We will also determine the concordance between point-of-care G6PD tests and the spectrophotometric gold standard. This study will also access the sensitivity and specificity between the point-of-care G6PD tests. This study will take place in Indonesia, specifically in the SW Sumba region. We will enroll 700 volunteers.

Study Type

Observational

Enrollment (Actual)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia
        • Eijkman Institute for Molecular Biology

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

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We will enroll up to 700 volunteers from the SW Sumba region in Indonesia. The SW Sumba region is inland, and isolated from other nearby villages. The general population of SW Sumba are substance farmers.

Description

Inclusion Criteria:

  • Subjects must be at least five years of age
  • Patient / parental consent
  • Patient willing to allow donated sample to be used in future research

Exclusion Criteria:

  • Patients with severe malaria or other severe illness
  • Patients who received a blood transfusion in the last three months
  • Patients unwilling to allow donated blood to be used in future research

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

Cohorts and Interventions

Group / Cohort
G6PD testing
Blood samples will be tested for G6PD activity levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine concordance between point-of-care tests and spectrophotometric gold standard
Time Frame: Six months
Percent agreement between the quantitative results of the G6PD tests and the spectrophotometric test.
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine sensitivity and specificity of the point-of-care G6PD tests against the spectrophotometric gold standard
Time Frame: Six months
This is to determine the variance of the sensitivity and specificity of different G6PD point-of-care tests compared to the gold standard.
Six months
Measure categorical accuracy of point-of-care G6PD test against by the spectrophotometric gold standard
Time Frame: Six months
Percent agreement between the qualitative G6PD test and the categorical results of the spectrophotometric gold standard
Six months
Determine concordance between point-of-care G6PD tests and the florescent spot test
Time Frame: Six months
Compare sensitivity & specificity of qualitative results of the G6PD test and the categorical results of the florescent spot test.
Six months
Define the G6PD-normal and deficient profiles in the SW Sumba population.
Time Frame: Six months
Determine the profile of the SW Sumba area in regards to normal and deficient population spread.
Six months

Collaborators and Investigators

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

Sponsor

PATH

Collaborators

Eijkman Institute for Molecular Biology

Investigators

  • Study Chair: Ari Winasti Satyagraha, PhD, Eijkman Institute for Molecular Biology
  • Study Chair: Kevin Baird, PhD, Eijkman Oxford Clinical Research Unit, Indonesia

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

April 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

April 1, 2014

First Submitted That Met QC Criteria

April 3, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Estimate)

October 28, 2014

Last Update Submitted That Met QC Criteria

October 27, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Eijkman-69

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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