Status:
COMPLETED
Evaluation of a Diagnostic to Identify Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Brazil
Lead Sponsor:
PATH
Collaborating Sponsors:
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Conditions:
G6PD Deficiency
Eligibility:
All Genders
2+ years
Phase:
NA
Brief Summary
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 te...
Detailed Description
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 sur...
Eligibility Criteria
Inclusion
- Participants with unknown G6PD status
- Inclusion criteria:
- Febrile patients seeking care at the Manaus or Porto Velho clinics
- 2 years age or older
- Willing to provide informed consent
- Exclusion criteria
- Younger than 2 years of age
- Participants who received a blood transfusion in the last 3 months, self report
- Unwilling to provide informed consent
- Participants with known G6PD status
- Inclusion criteria:
- Included in previous G6PD surveys and provided consent to be contacted again
- 2 years of age or older
- Willing to provide informed consent or assent
- Exclusion criteria:
- Younger than 2 years of age
- Participants who received a blood transfusion in the last 3 months, self report
- Unwilling to provide informed consent or assent or unavailable during study visit
- Health workers
- Provides malaria case management at study facility or study site
- Considered an intended user of quantitative POC G6PD tests
- Trained and proficient in the use of the POC G6PD test
- Willing to provide informed consent
Exclusion
- Does not provide malaria case management at study facility or study site
- Not considered an intended user of quantitative POC G6PD tests
- Not trained or not proficient in the use of the POC G6PD test
- Unwilling to provide informed consent
Key Trial Info
Start Date :
June 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
1754 Patients enrolled
Trial Details
Trial ID
NCT04033640
Start Date
June 27 2019
End Date
December 31 2019
Last Update
November 11 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Tropical Medicine Foundation Doctor Heitor Vieira Dourado
Manaus, Amazonas, Brazil
2
Centro de Pesquisa em Medicina Tropical de Rondônia
Porto Velho, Rondônia, Brazil