G6PD DeficiencyNCT04033640
Evaluation of a Diagnostic to Identify Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Brazil
A study testing SD Biosensor STANDARD G6PD Test, Pointe Scientific Test Kit and HemoCue System in people with G6PD Deficiency, run by PATH at 2 sites in Brazil.
Trial 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 test packaging and labelling among intended users To assess the usability of G6PD test result outputs among intended users Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- G6PD Deficiency
- What is being tested?
- SD Biosensor STANDARD G6PD Test, Pointe Scientific Test Kit and HemoCue System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,754 participants
- Where
- 2 sitesBrazil
- Study dates
- 27 Jun 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Febrile patients seeking care at the Manaus or Porto Velho clinics
- 2 years age or older
- Willing to provide informed consent
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
- Younger than 2 years of age
- Participants who received a blood transfusion in the last 3 months, self report
Show all 12Show fewer
- Unwilling to provide informed consent or assent or unavailable during study visit
- Health workers
- 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
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Tropical Medicine Foundation Doctor Heitor Vieira Dourado
Manaus, Amazonas
Centro de Pesquisa em Medicina Tropical de Rondônia
Porto Velho, Rondônia
About this study
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
Read the 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 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.
- Conditions
- G6PD Deficiency
- Being tested
- SD Biosensor STANDARD G6PD Test, Pointe Scientific Test Kit, HemoCue System, Complete blood count (CBC)
- Keywords
- G6PD deficiency
- Medical subject headings
- Glucosephosphate Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SD Biosensor STANDARD G6PD TestDiagnostic test
The SD Biosensor G6PD Analyzer is designed to measure the quantitative determination of total hemoglobin concentration and G6PD enzymatic activity in fresh human whole blood specimens based on reflectometry assays in a point-of-care (POC) setting. The test is intended to aid in the identification of people with G6PD deficiency.
The test is currently not licensed for use in Brazil and is considered an investigational product.
Pointe Scientific Test KitDiagnostic test
The Pointe Scientific test kit will serve as the reference assay to assess G6PD activity. Its intended use is for the quantitative, kinetic determination of G6PD in blood at 340 nm.
HemoCue SystemDiagnostic test
The HemoCue hemoglobin (Hb) 201+ system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 201+ Analyzer, and specially designed microcuvettes, the HemoCue Hb 201+Microcuvettes.
Complete blood count (CBC)Diagnostic test
In Manaus, hemoglobin concentration was determined by CBC using an automated hematology analyzer (Sysmex KX-21N).
| Study group | Role | What they receive |
|---|---|---|
| G6PD Diagnostic Testing | Other | Participants provided whole blood samples as well as finger-stick capillary blood samples.
At the clinic site, study staff performed the SD Biosensor STANDARD G6PD test and the POC HemoCue hemoglobin test on finger stick blood samples.
At the reference laboratories, G6PD activity was measured from whole blood samples using the SD Biosensor STANDARD G6PD test and the Pointe Scientific G6PD reference assay and hemoglobin was measured using the HemoCue hemoglobin test and by a complete blood count (CBC) using an automated hematology analyzer (Manaus site only). Receives: Diagnostic Test: SD Biosensor STANDARD G6PD Test; Diagnostic Test: Pointe Scientific Test Kit; Diagnostic Test: HemoCue System; Diagnostic Test: Complete blood count (CBC) |
| Health Workers | No intervention | Participants were trained on use of the SD Biosensor STANDARD G6PD test by members of the study team with extensive experience with G6PD diagnostics and the STANDARD G6PD test. Health worker participants were surveyed to assess label and packing comprehension as well as results interpretation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals
For the purposes of this study, an individual was considered G6PD deficient if they tested positive in the Pointe Scientific assay. A true positive was defined as a participant with ≤ 30% of normal G6PD activity in circulating venous blood determined by the Pointe Scientific test.
Diagnostic sensitivity of the SD Biosensor STANDARD G6PD test is defined as the percentage of participants who tested positive for G6PD deficiency on the reference test who were identified by the test assay as positive, calculated as:
Number of participants who were both test and true positive / (Number of participants who were test and true positive + Number of participants who were test negative but true positive [ie false negative]) * 100%.
Sensitivity of the SD Biosensor STANDARD G6PD test was calculated from both venous and capillary blood samples.
Measured: All samples were collected on study day 1
Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity
To investigate the performance of the SD Biosensor STANDARD G6PD test to distinguish females with intermediate G6PD activity from females with normal activity, assay sensitivity was determined at a G6PD activity threshold of 70%. A true positive for intermediate G6PD activity in females was defined as G6PD activity between 30 and 70% of normal in circulating venous blood as determined by the Pointe Scientific test.
Sensitivity of the SD Biosensor STANDARD G6PD test is the percentage of women who tested positive for intermediate G6PD activity on the reference test who were identified by the test assay as positive, calculated as:
Number of women who were both test and true positive / (Number of women who were test and true positive + Number of women who were test negative but true positive [ie false negative]) * 100%.
Sensitivity of the SD Biosensor STANDARD G6PD test for identifying females with intermediate G6PD activity was calculated from both venous and capillary blood samples.
Measured: All samples were collected on study day 1
Specificity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals
For the purposes of this study, an individual was considered G6PD deficient if they tested positive by the Pointe Scientific assay. A true negative was defined as > 30% of normal G6PD activity in circulating venous blood as determined by the Pointe Scientific test.
Specificity is the percentage of participants who tested negative for G6PD deficiency on the reference test who were identified as negative using the test assay, calculated as:
Number of participants who were both test and true negative / (Number of participants who were test and true negative + Number of participants who were test positive but true negative [ie false positive]) * 100%.
Specificity of the SD Biosensor STANDARD G6PD test was calculated from both venous and capillary blood samples.
Measured: All samples were collected on study day 1
Specificity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity
To investigate the performance of the SD Biosensor STANDARD G6PD test to distinguish females with intermediate G6PD activity from females with normal activity, the specificity was determined at a G6PD activity threshold of 70%. A true negative for intermediate G6PD activity in females was defined as G6PD activity > 70% of normal in circulating venous blood as determined by the Pointe Scientific test.
Specificity is the percentage of participants who tested negative for G6PD deficiency on the reference test who were identified as negative using the test assay, calculated as: Number of participants who were both test and true negative / (Number of participants who were test and true negative + Number of participants who were test positive but true negative [ie false positive]) * 100%.
Specificity of the SD Biosensor STANDARD G6PD test was calculated from both venous and capillary blood samples.
Measured: All samples were collected on study day 1
Secondary outcomes (6)
Accuracy Between the SD Biosensor STANDARD G6PD Test Assay and the Pointe Scientific Test Kit
Accuracy between the SD Biosensor STANDARD G6PD test assay and the Pointe Scientific G6PD reference assay was calculated as the percent agreement between both G6PD tests, ie, the percentage of participants with the same diagnosis according to both tests (either deficient, intermediate, or normal G6PD levels).
Accuracy of the SD Biosensor STANDARD G6PD test was calculated from both venous and capillary blood samples.
Measured: All samples were collected on study day 1
Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Reference HemoCue Hemoglobin Test
Accuracy between the SD Biosensor STANDARD G6PD test measure of hemoglobin and the HemoCue hemoglobin reference assay was calculated as the percentage agreement between both tests, ie, the percentage of participants with the same diagnosis according to both tests (either non/mild anemia, moderate anemia or severe anemia).
Measured: All samples were collected on study day 1
Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Hemoglobin Measured in a Complete Blood Count
Accuracy between the SD Biosensor STANDARD G6PD test measure of hemoglobin and the hemoglobin result from the complete blood count (CBC) reference assay (using an automated hematology analyzer) was calculated as the percentage agreement between both tests, ie, the percentage of participants with the same diagnosis according to both tests (either non/mild anemia, moderate anemia or severe anemia). Complete blood counts were only conducted for participants enrolled at the site in Manaus.
Measured: All samples were collected on study day 1
Median G6PD Values Measured by the SD Biosensor STANDARD G6PD Test for Venous and Capillary Blood Samples
Measured: All samples were collected on study day 1
Number of Participants Who Met Acceptance Criteria for Label Comprehension
After completing training, health worker participants were asked to complete a questionnaire to assess their comprehension of the test label. The questionnaire consisted of 13 multiple-choice questions with mutually exclusive options and a single correct answer focused on aspects of the product label including key warnings, limitations, and restrictions as well as the proper test procedure.
Acceptance (success) criterion for label comprehension was defined as at least 85% correct responses (11 out of 13 possible points).
Measured: Day 1
Number of Participants Who Met Acceptance Criteria for Accurate Results Interpretation
After completing training, health worker participants were asked to complete a questionnaire to assess their ability to interpret the test result outputs. The questionnaire consisted of seven short-answer questions (5 valid results, 2 invalid results) focused on the participant's ability to read the results screen, record the simulated G6PD and hemoglobin quantitative results, and classify the results as normal, intermediate, deficient, or invalid.
For each valid result, three points were possible: (one for G6PD result transcription, one for hemoglobin result transcription, and one for result interpretation) and for each invalid result, one point was possible, resulting in a total of 17 possible points.
Acceptance (success) criterion for results interpretation was defined as at least 85% correct responses (15 out of 17 possible points).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start27 Jun 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for G6PD DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,754 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
- Responsible party
- Sponsor
- Investigators
- Marcus Lacerda, MD, PhD, Principal investigator, FMT/HVD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033640
- Sponsor's protocol ID
- G6PD Brazil
- Status last verified
- Sep 2021
- First submitted
- 17 Jul 2019
- Last updated
- 11 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share any IPD with other researchers.
Publications
Zobrist S, Brito M, Garbin E, Monteiro WM, Clementino Freitas S, Macedo M, Soares Moura A, Advani N, Kahn M, Pal S, Gerth-Guyette E, Bansil P, Domingo GJ, Pereira D, Lacerda MV. Evaluation of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency in Brazil. PLoS Negl Trop Dis. 2021 Aug 12;15(8):e0009649. doi: 10.1371/journal.pntd.0009649. eCollection 2021 Aug.
PubMed 34383774Gerth-Guyette E, Adissu W, Brito M, Garbin E, Macedo M, Sharma A, Das S, Lacerda MVG, Pereira D, Talukdar A, Yilma D, Pal S, Zobrist S, Domingo GJ. Usability of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency: a multi-country assessment of test label comprehension and results interpretation. Malar J. 2021 Jul 8;20(1):307. doi: 10.1186/s12936-021-03803-1.
PubMed 34238299
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Diagnostic to Identify G6PD Deficiency in Brazil
- ClinicalTrials.gov ID
- NCT04033640
- Acronym / sponsor ID
- G6PD Brazil
- Conditions
- G6PD Deficiency
- Keywords
- G6PD deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,754 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Posted 11 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G6PD Diagnostic Testing | Other | Diagnostic Test: SD Biosensor STANDARD G6PD Test, Diagnostic Test: Pointe Scientific Test Kit, Diagnostic Test: HemoCue System, Diagnostic Test: Complete blood count (CBC)Participants provided whole blood samples as well as finger-stick capillary blood samples. At the clinic site, study staff performed the SD Biosensor STANDARD G6PD test and the POC HemoCue hemoglobin test on finger stick blood samples. At the reference laboratories, G6PD activity was measured from whole blood samples using the SD Biosensor STANDARD G6PD test and the Pointe Scientific G6PD reference assay and hemoglobin was measured using the HemoCue hemoglobin test and by a complete blood count (CBC) using an automated hematology analyzer (Manaus site only). |
| Health Workers | No intervention | –Participants were trained on use of the SD Biosensor STANDARD G6PD test by members of the study team with extensive experience with G6PD diagnostics and the STANDARD G6PD test. Health worker participants were surveyed to assess label and packing comprehension as well as results interpretation. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- Participants with known G6PD status
- Health workers
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SD Biosensor STANDARD G6PD TestThe SD Biosensor G6PD Analyzer is designed to measure the quantitative determination of total hemoglobin concentration and G6PD enzymatic activity in fresh human whole blood specimens based on reflectometry assays in a point-of-care (POC) setting. The test is intended to aid in the identification of people with G6PD deficiency. The test is currently not licensed for use in Brazil and is considered an investigational product. | Diagnostic test | G6PD Diagnostic Testing |
| Pointe Scientific Test KitThe Pointe Scientific test kit will serve as the reference assay to assess G6PD activity. Its intended use is for the quantitative, kinetic determination of G6PD in blood at 340 nm. | Diagnostic test | G6PD Diagnostic Testing |
| HemoCue SystemThe HemoCue hemoglobin (Hb) 201+ system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 201+ Analyzer, and specially designed microcuvettes, the HemoCue Hb 201+Microcuvettes. | Diagnostic test | G6PD Diagnostic Testing |
| Complete blood count (CBC)In Manaus, hemoglobin concentration was determined by CBC using an automated hematology analyzer (Sysmex KX-21N). | Diagnostic test | G6PD Diagnostic Testing |
Primary outcome
Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals
Time frame: All samples were collected on study day 1
For the purposes of this study, an individual was considered G6PD deficient if they tested positive in the Pointe Scientific assay. A true positive was defined as a participant with ≤ 30% of normal G6PD activity in circulating venous blood determined by the Pointe Scientific test. Diagnostic sensitivity of the SD Biosensor STANDARD G6PD test is defined as the percentage of participants who tested positive for G6PD deficiency on the reference test who were identified by the test assay as positive, calculated as: Number of participants who were both test and true positive / (Number of participants who were test and true positive + Number of participants who were test negative but true positive [ie false negative]) * 100%. Sensitivity of the SD Biosensor STANDARD G6PD test was calculated from both venous and capillary blood samples.
Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity
Time frame: All samples were collected on study day 1
To investigate the performance of the SD Biosensor STANDARD G6PD test to distinguish females with intermediate G6PD activity from females with normal activity, assay sensitivity was determined at a G6PD activity threshold of 70%. A true positive for intermediate G6PD activity in females was defined as G6PD activity between 30 and 70% of normal in circulating venous blood as determined by the Pointe Scientific test. Sensitivity of the SD Biosensor STANDARD G6PD test is the percentage of women who tested positive for intermediate G6PD activity on the reference test who were identified by the test assay as positive, calculated as: Number of women who were both test and true positive / (Number of women who were test and true positive + Number of women who were test negative but true positive [ie false negative]) * 100%. Sensitivity of the SD Biosensor STANDARD G6PD test for identifying females with intermediate G6PD activity was calculated from both venous and capillary blood samples.
Specificity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals
Time frame: All samples were collected on study day 1
For the purposes of this study, an individual was considered G6PD deficient if they tested positive by the Pointe Scientific assay. A true negative was defined as > 30% of normal G6PD activity in circulating venous blood as determined by the Pointe Scientific test. Specificity is the percentage of participants who tested negative for G6PD deficiency on the reference test who were identified as negative using the test assay, calculated as: Number of participants who were both test and true negative / (Number of participants who were test and true negative + Number of participants who were test positive but true negative [ie false positive]) * 100%. Specificity of the SD Biosensor STANDARD G6PD test was calculated from both venous and capillary blood samples.
Specificity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity
Time frame: All samples were collected on study day 1
To investigate the performance of the SD Biosensor STANDARD G6PD test to distinguish females with intermediate G6PD activity from females with normal activity, the specificity was determined at a G6PD activity threshold of 70%. A true negative for intermediate G6PD activity in females was defined as G6PD activity > 70% of normal in circulating venous blood as determined by the Pointe Scientific test. Specificity is the percentage of participants who tested negative for G6PD deficiency on the reference test who were identified as negative using the test assay, calculated as: Number of participants who were both test and true negative / (Number of participants who were test and true negative + Number of participants who were test positive but true negative [ie false positive]) * 100%. Specificity of the SD Biosensor STANDARD G6PD test was calculated from both venous and capillary blood samples.
6 secondary outcomes
Accuracy Between the SD Biosensor STANDARD G6PD Test Assay and the Pointe Scientific Test Kit
Time frame: All samples were collected on study day 1
Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Reference HemoCue Hemoglobin Test
Time frame: All samples were collected on study day 1
Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Hemoglobin Measured in a Complete Blood Count
Time frame: All samples were collected on study day 1
Median G6PD Values Measured by the SD Biosensor STANDARD G6PD Test for Venous and Capillary Blood Samples
Time frame: All samples were collected on study day 1
Number of Participants Who Met Acceptance Criteria for Label Comprehension
Time frame: Day 1
Number of Participants Who Met Acceptance Criteria for Accurate Results Interpretation
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34383774Zobrist S, Brito M, Garbin E, Monteiro WM, Clementino Freitas S, Macedo M, Soares Moura A, Advani N, Kahn M, Pal S, Gerth-Guyette E, Bansil P, Domingo GJ, Pereira D, Lacerda MV. Evaluation of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency in Brazil. PLoS Negl Trop Dis. 2021 Aug 12;15(8):e0009649. doi: 10.1371/journal.pntd.0009649. eCollection 2021 Aug.
- Derived from this study: PubMed 34238299Gerth-Guyette E, Adissu W, Brito M, Garbin E, Macedo M, Sharma A, Das S, Lacerda MVG, Pereira D, Talukdar A, Yilma D, Pal S, Zobrist S, Domingo GJ. Usability of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency: a multi-country assessment of test label comprehension and results interpretation. Malar J. 2021 Jul 8;20(1):307. doi: 10.1186/s12936-021-03803-1.
- Individual participant dataSharing planned: No. There is no plan to share any IPD with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Lacerda, MD, PhD principal investigator
FMT/HVD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SD Biosensor STANDARD G6PD Test, Pointe Scientific Test Kit and HemoCue System in people with G6PD Deficiency, run by PATH at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals (time frame: All samples were collected on study day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04033640, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.