Evaluation of Different G6PD Testing Platforms

NCT ID: NCT02104518

Last Updated: 2014-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glucose-6-Phosphate Dehydrogenase Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

G6PD testing

Blood samples will be tested for G6PD activity levels

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eijkman Institute for Molecular Biology

OTHER

Sponsor Role collaborator

PATH

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ari Winasti Satyagraha, PhD

Role: STUDY_CHAIR

Eijkman Institute for Molecular Biology

Kevin Baird, PhD

Role: STUDY_CHAIR

Oxford University Clinical Research Unit Indonesia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Eijkman Institute for Molecular Biology

Jakarta, , Indonesia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Eijkman-69

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Podocyts Integrity in Glomerular Diseases
NCT05875454 NOT_YET_RECRUITING