Glucose-6-Phosphate Dehydrogenase Deficiency Clinical Trial
Official title:
Evaluation of a Point-of-care G6PD Diagnostic Test
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 |
In this study the investigators propose to evaluate the performance of several G6PD testing platforms.
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 |
Observational Model: Ecologic or Community, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Indonesia | Eijkman Institute for Molecular Biology | Jakarta |
Lead Sponsor | Collaborator |
---|---|
PATH | Eijkman Institute of Molecular Biology |
Indonesia,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT02498340 -
Diet Challenge in G6PD Deficient Egyptian Children: A One- Year Prospective Single Center Study With Genotype - Phenotype Correlation
|
Phase 2/Phase 3 |