PaludismG6PD facileNCT04698980
Evaluation of the STANDARD G6PD Rapid Test for Assaying the Enzymatic Activity of G6PD in French Guiana
A study testing blood samples (venous and capillary at the fingertip) in people with Paludism, run by Institut Pasteur at 1 site in French Guiana.
Trial summary
In French Guiana, malaria is endemic and two species predominate: P. falciparum and P. vivax. The treatments against Plasmodium vivax malaria are: nivaquine for 3 days against circulating blood parasites and primaquine for 14 days against parasites dormant in the liver. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Paludism
- What is being tested?
- blood samples (venous and capillary at the fingertip)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrench Guiana
- Study dates
- 5 May 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- People with a known level of G6PD activity.
- People or their legal representatives who have received information on the research and have signed a written consent to participate in the study
- People aged over 18 for the "intermediate" and "normal" categories,
- People aged two years and over for the "severe deficit" category.
Who cannot join
- People with an unknown level of G6PD activity,
- People or their legal representatives who refused to participate in the study,
- People aged under 18 for the intermediate and normal categories,
- Children under 2 years old for the "severe deficit" category,
- People with a hemoglobin level below 11g / dL for men and 10g / dL for women and children.
- People who received a transfusion less than 4 months before the proposal to participate in the G6PD study
Trial locations and contacts
1 site in 1 country.
French Guiana1 site, 1 recruiting
- Recruiting
Institut Pasteur de la Guyane
Cayenne
Lise Musset
About this study
In French Guiana, malaria is endemic and two species predominate: P. falciparum and P. vivax. The treatments against Plasmodium vivax malaria are: nivaquine for 3 days against circulating blood parasites and primaquine for 14 days against parasites dormant in the liver. Primaquine can cause iatrogenic hemolytic anemias in patients with favism, i.e. G6PD deficiency. This anemia can be severe enough to cause the death of the deficient patient. Thus, the WHO and HCSP recommendations indicate that a quantitative assay of the activity of this enzyme should be carried out before its prescription. This deficiency is a recessive inherited disease linked to the X chromosome characterized by more or less low levels of enzymatic activity which depends on the genotype of the patients but not only because the phenotype depends on the level of activation of the X chromosome for each cell.
Currently, obtaining a G6PD assay in French Guiana is a long process since it is done in mainland France and the pre-analytical conditions are quite demanding. Thus, in areas of transmission of P. vivax, patients usually have a bout of revival before being prescribed primaquine. This period includes: dosing G6PD at a distance from access, obtaining the result and then the nominal ATU to finally obtain and deliver the primaquine.
Read the detailed description
This is a interventional,prospective, multicenter, cross-sectional and comparative study.
To achieve this study, the following will be done:
- Selection of subjects according to their G6PD activity from the list of participants previously included in the ELIMALAR Palustop study and from known LHUPM patients in Cayenne following a request for a G6PD dosage, whether or not related to malaria.
- Collection of clinical data from participants (sex, age, ethnicity of parents and grandparents).
- Collection of blood samples from subjects showing G6PD activity of the following three categories "severe deficiency", "intermediate", "normal".
- Determination of G6PD activity by the "STANDARD G6PD" technique from SD BIOSENSOR versus the reference enzymatic method
- Conditions
- Paludism
- Being tested
- blood samples (venous and capillary at the fingertip)
- Keywords
- paludism, French Guiana, G6PD, rapid diagnostic test, STANDARD G6PD
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samples (venous and capillary at the fingertip)Diagnostic test
For each participant, the intervention will be a fingertip sample to perform the STANDARD G6PD test and two blood samples on EDTA to perform the reference test
| Study group | Role | What they receive |
|---|---|---|
| participants selected according to their G6PD activity | Other | * 50 subjects with "severe deficit" G6PD activity (<30% of the median in the general population, ie 3.6U / g Hb), adults or children two years and over.
* 50 subjects with "intermediate" G6PD activity (30-80%), adults.
* 50 subjects with "normal" G6PD activity (> 80% ie> 9.6U / g Hb), adults. Receives: Diagnostic Test: blood samples (venous and capillary at the fingertip) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the STANDARD G6PD test
The sensitivity and specificity will be calculated for the detection of severe deficits in G6PD activity (<30%), intermediate activities (30-80%) and normal activities (> 80%) of the STANDARD G6PD test vs the reference enzymatic method
Measured: 3 years
Secondary outcomes (4)
Verification of the analysis method by the STANDARD G6PD test several times
Measurement of the G6PD activity will be done to assess the repeatability, accuracy or trueness of the STANDARD G6PD test according to the recommendations of standard NF EN ISO 15189: 2012 for accreditation.
Measured: 3 years
Verification of the analysis method by the STANDARD G6PD test by different operator
Measurement of the G6PD activity will be done to assess the inter-operator variability, of the STANDARD G6PD test according to the recommendations of standard NF EN ISO 15189: 2012 for accreditation.
Measured: 3 years
Verification of the analysis method by the STANDARD G6PD test in different conditions
Measurement of the G6PD activity will be done to assess the reproducibility, robustness and measurement interval of the STANDARD G6PD test according to the recommendations of standard NF EN ISO 15189: 2012 for accreditation.
Measured: 3 years
sequencing of the coding regions of the G6PD gene of 150 individuals
Analysis of the genotype of the G6PD gene and comparison to the phenotype
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start5 May 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PaludismStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 150 participants selected according to their G6PD activity: * 50 subjects with "severe deficit" G6PD activity (\<30% of the median in the general population, ie 3.6U / g Hb), adults or children two years and over. * 50 subjects with "intermediate" G6PD activity (30-80%), adults. * 50 subjects with "normal" G6PD activity (\> 80% ie\> 9.6U / g Hb), adults.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur de la Guyane, Centre Hospitalier Andrée Rosemon de Cayenne
- Responsible party
- Sponsor
- Investigators
- Lise Musset, PharmD, Principal investigator, Institut Pasteur de la Guyane, head of Parasitology laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698980
- Sponsor's protocol ID
- 2019-015
- Acronym
- G6PD facile
- Status last verified
- Nov 2022
- First submitted
- 18 Dec 2020
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the STANDARD G6PD Rapid Test for Assaying the Enzymatic Activity of G6PD in French Guiana
- ClinicalTrials.gov ID
- NCT04698980
- Acronym / sponsor ID
- G6PD facile / 2019-015
- Conditions
- Paludism
- Keywords
- paludism, French Guiana, G6PD, rapid diagnostic test, STANDARD G6PD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur de la Guyane, Centre Hospitalier Andrée Rosemon de Cayenne
- Study start
- 5 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In French Guiana, malaria is endemic and two species predominate: P. falciparum and P. vivax. The treatments against Plasmodium vivax malaria are: nivaquine for 3 days against circulating blood parasites and primaquine for 14 days against parasites dormant in the liver. Primaquine can cause iatrogenic hemolytic anemias in patients with favism, i.e. G6PD deficiency. This anemia can be severe enough to cause the death of the deficient patient. Thus, the WHO and HCSP recommendations indicate that a quantitative assay of the activity of this enzyme should be carried out before its prescription. This deficiency is a recessive inherited disease linked to the X chromosome characterized by more or less low levels of enzymatic activity which depends on the genotype of the patients but not only because the phenotype depends on the level of activation of the X chromosome for each cell.
Currently, obtaining a G6PD assay in French Guiana is a long process since it is done in mainland France and the pre-analytical conditions are quite demanding. Thus, in areas of transmission of P. vivax, patients usually have a bout of revival before being prescribed primaquine. This period includes: dosing G6PD at a distance from access, obtaining the result and then the nominal ATU to finally obtain and deliver the primaquine.
Detailed description
This is a interventional,prospective, multicenter, cross-sectional and comparative study.
To achieve this study, the following will be done:
- Selection of subjects according to their G6PD activity from the list of participants previously included in the ELIMALAR Palustop study and from known LHUPM patients in Cayenne following a request for a G6PD dosage, whether or not related to malaria.
- Collection of clinical data from participants (sex, age, ethnicity of parents and grandparents).
- Collection of blood samples from subjects showing G6PD activity of the following three categories "severe deficiency", "intermediate", "normal".
- Determination of G6PD activity by the "STANDARD G6PD" technique from SD BIOSENSOR versus the reference enzymatic method
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 150 participants selected according to their G6PD activity: * 50 subjects with "severe deficit" G6PD activity (<30% of the median in the general population, ie 3.6U / g Hb), adults or children two years and over. * 50 subjects with "intermediate" G6PD activity (30-80%), adults. * 50 subjects with "normal" G6PD activity (> 80% ie> 9.6U / g Hb), adults.
| Arm | Type | Receives |
|---|---|---|
| participants selected according to their G6PD activity | Other | Diagnostic Test: blood samples (venous and capillary at the fingertip)* 50 subjects with "severe deficit" G6PD activity (<30% of the median in the general population, ie 3.6U / g Hb), adults or children two years and over. * 50 subjects with "intermediate" G6PD activity (30-80%), adults. * 50 subjects with "normal" G6PD activity (> 80% ie> 9.6U / g Hb), adults. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- People with a known level of G6PD activity.
- People or their legal representatives who have received information on the research and have signed a written consent to participate in the study
- People aged over 18 for the "intermediate" and "normal" categories,
- People aged two years and over for the "severe deficit" category.
Key exclusion criteria (6 listed)
- People with an unknown level of G6PD activity,
- People or their legal representatives who refused to participate in the study,
- People aged under 18 for the intermediate and normal categories,
- Children under 2 years old for the "severe deficit" category,
- People with a hemoglobin level below 11g / dL for men and 10g / dL for women and children.
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 |
|---|---|---|
| blood samples (venous and capillary at the fingertip)For each participant, the intervention will be a fingertip sample to perform the STANDARD G6PD test and two blood samples on EDTA to perform the reference test | Diagnostic test | participants selected according to their G6PD activity |
Primary outcome
Sensitivity and specificity of the STANDARD G6PD test
Time frame: 3 years
The sensitivity and specificity will be calculated for the detection of severe deficits in G6PD activity (<30%), intermediate activities (30-80%) and normal activities (> 80%) of the STANDARD G6PD test vs the reference enzymatic method
4 secondary outcomes
Verification of the analysis method by the STANDARD G6PD test several times
Time frame: 3 years
Verification of the analysis method by the STANDARD G6PD test by different operator
Time frame: 3 years
Verification of the analysis method by the STANDARD G6PD test in different conditions
Time frame: 3 years
sequencing of the coding regions of the G6PD gene of 150 individuals
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
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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.
Lise Musset, PharmD principal investigator
Institut Pasteur de la Guyane, head of Parasitology laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples (venous and capillary at the fingertip) in people with Paludism, run by Institut Pasteur at 1 site in French Guiana.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in French Guiana. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Musset, PharmD (+335 94 29 68 40, lmusset@pasteur-cayenne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the STANDARD G6PD test (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2022.