Clinical trial NCT04698980: Evaluation of the STANDARD G6PD Rapid Test for Assaying the Enzymatic Activity of G6PD in French Guiana
Official title: Evaluation of the STANDARD G6PD Rapid Test for Assaying the Enzymatic Activity of G6PD in French Guiana
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paludism
Keywords: paludism
French Guiana
G6PD
rapid diagnostic test
STANDARD G6PD
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Institut Pasteur de la Guyane
name: Centre Hospitalier Andrée Rosemon de Cayenne
First posted: 2021-01-07
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sensitivity and specificity of the STANDARD G6PD test
timeFrame: 3 years
Secondary outcomes:
measure: Verification of the analysis method by the STANDARD G6PD test several times
timeFrame: 3 years
measure: Verification of the analysis method by the STANDARD G6PD test by different operator
timeFrame: 3 years
measure: Verification of the analysis method by the STANDARD G6PD test in different conditions
timeFrame: 3 years
measure: sequencing of the coding regions of the G6PD gene of 150 individuals
timeFrame: 3 years
Other outcomes:
Locations:
city: Cayenne
country: French Guiana
facility: Institut Pasteur de la Guyane
Study officials:
affiliation: Institut Pasteur de la Guyane, head of Parasitology laboratory
name: Lise Musset, PharmD
role: PRINCIPAL_INVESTIGATOR
References: