G6PD Deficiency Clinical Trial
Official title:
Evaluation of a Diagnostic to Identify G6PD Deficiency in Brazil
Th objectives of this study are: - To determine the performance of G6PD tests in detecting G6PD activity and hemoglobin (Hb) compared to a reference assay - To assess the comprehension of the G6PD test packaging and labelling among intended users - To assess the usability of G6PD test result outputs among intended users
This is a cross-sectional diagnostic accuracy study that includes both participants and health worker participants. The participant population will be recruited at clinics and through a household survey using an enriched sample of a population with known G6PD status, established through previous epidemiological studies. Clinic staff will take capillary blood samples and conduct two point of care (POC) tests: 1) HemoCue® hemoglobin test, and 2) the investigational Standard Diagnostics (SD) Biosensor STANDARD POC test for glucose-6-phosphate dehydrogenase (G6PD) deficiency. Venous blood will be collected and transferred to a laboratory where reference assays will be performed on venous samples using the Pointe Scientific G6PD Analyzer and hemoglobin tests. The health worker participants will include trained intended users of the G6PD tests. Trained health workers will be surveyed to assess product usability through a questionnaire to assess label and packing comprehension as well as results interpretation. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05096702 -
Operational Feasibility of Appropriate Radical Cure of Plasmodium Vivax With Tafenoquine or Primaquine After Quantitative G6PD Testing in Brazil
|
||
| Recruiting |
NCT04073953 -
Primaquine Enantiomers in G6PD Deficient Human Volunteers
|
Phase 1 | |
| Completed |
NCT02434952 -
Safety and Tolerability of Low Dose Primaquine
|
Phase 4 | |
| Enrolling by invitation |
NCT03655223 -
Early Check: Expanded Screening in Newborns
|
||
| Completed |
NCT04081272 -
Effect of G6PD Deficiency on Red Blood Cell Storage
|
||
| Completed |
NCT04146246 -
Comparative Evaluation of the FINDER Instrument and FINDER G6PD Cartridge in Adults and Neonates
|
||
| Recruiting |
NCT05026489 -
G6PD Deficiency in Infarction Patients in Shaanxi Province
|
||
| Terminated |
NCT03337152 -
Assessing a Risk Model for G6PD Deficiency
|
Phase 4 | |
| Completed |
NCT05753150 -
Operational Feasibility of Appropriate Plasmodium Vivax Radical Cure After G6PD Testing in Thailand
|
||
| Completed |
NCT04010695 -
Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US
|
N/A | |
| Completed |
NCT01931644 -
At-Home Research Study for Patients With Autoimmune, Inflammatory, Genetic, Hematological, Infectious, Neurological, CNS, Oncological, Respiratory, Metabolic Conditions
|
||
| Active, not recruiting |
NCT03529396 -
Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in G6PD Deficient Patients
|
Phase 2 | |
| Recruiting |
NCT05874271 -
Short Course Primaquine for the Radical Cure of P. Vivax - Papua New Guinea
|
N/A | |
| Recruiting |
NCT04088513 -
Safety and Efficacy of Aspirin in Stroke Patients With Glucose-6-phosphate Dehydrogenase Deficiency (SAST)
|
Phase 4 | |
| Not yet recruiting |
NCT05571748 -
Oxidative Stress, Carbohydrate Metabolism Disorders and G6PD Deficiency
|
N/A | |
| Not yet recruiting |
NCT02937376 -
Effects of N-acetyl Cystein (NAC) Supplementation in G6PD Deficient Individuals After Acute Exercise
|
Early Phase 1 | |
| Completed |
NCT02937363 -
Effects of Alpha Lipoic Acid Supplementation in G6PD Deficient Individuals After Acute Exercise
|
N/A | |
| Recruiting |
NCT05879224 -
Short Course Primaquine for the Radical Cure of P. Vivax Malaria - Indonesia
|
N/A | |
| Completed |
NCT04054661 -
Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Anti-coagulated Blood
|
N/A |