Evaluation of Different G6PD Testing Platforms

Glucose-6-Phosphate Dehydrogenase Deficiency Clinical Trial

Official title:

Evaluation of a Point-of-care G6PD Diagnostic Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104518
• Other study ID #: Eijkman-69
• Status: Completed
• Phase: N/A
• First received: April 1, 2014
• Last updated: October 27, 2014
• Start date: April 2014
• Est. completion date: June 2014

Study information

• Verified date: October 2014
• Source: PATH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years and older

Eligibility

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 Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glucose-6-Phosphate Dehydrogenase Deficiency
• Glucosephosphate Dehydrogenase Deficiency

Locations

Country	Name	City	State
Indonesia	Eijkman Institute for Molecular Biology	Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
PATH	Eijkman Institute of Molecular Biology

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine concordance between point-of-care tests and spectrophotometric gold standard	Percent agreement between the quantitative results of the G6PD tests and the spectrophotometric test.	Six months	No
Secondary	Determine sensitivity and specificity of the point-of-care G6PD tests against the spectrophotometric gold standard	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	No
Secondary	Measure categorical accuracy of point-of-care G6PD test against by the spectrophotometric gold standard	Percent agreement between the qualitative G6PD test and the categorical results of the spectrophotometric gold standard	Six months	No
Secondary	Determine concordance between point-of-care G6PD tests and the florescent spot test	Compare sensitivity & specificity of qualitative results of the G6PD test and the categorical results of the florescent spot test.	Six months	No
Secondary	Define the G6PD-normal and deficient profiles in the SW Sumba population.	Determine the profile of the SW Sumba area in regards to normal and deficient population spread.	Six months	No