Evaluation of the STANDARD G6PD Rapid Test for Assaying the Enzymatic Activity of G6PD in French Guiana

NCT ID: NCT04698980

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-05
• Study Completion Date: 2022-12-31

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

Conditions

Paludism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

blood samples (venous and capillary at the fingertip)

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Pasteur de la Guyane

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Andrée Rosemon de Cayenne

UNKNOWN

Sponsor Role: collaborator

Institut Pasteur

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lise Musset, PharmD

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur de la Guyane, head of Parasitology laboratory

Locations

Institut Pasteur de la Guyane

Cayenne, , French Guiana

Site Status: RECRUITING

Countries

French Guiana

Central Contacts

Lise Musset, PharmD

Role: CONTACT

lmusset@pasteur-cayenne.fr

+335 94 29 68 40

Facility Contacts

Lise Musset

Role: primary

Other Identifiers

2019-015

Identifier Type: -

Identifier Source: org_study_id