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

NCT04698980 | Unknown

• 1 other identifier: 2019-015
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Paludism

Keywords

paludism; French Guiana; G6PD; rapid diagnostic test; STANDARD G6PD

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Secondary Outcomes (4)

• Verification of the analysis method by the STANDARD G6PD test several times

  3 years

• Verification of the analysis method by the STANDARD G6PD test by different operator

  3 years

• Verification of the analysis method by the STANDARD G6PD test in different conditions

  3 years

• sequencing of the coding regions of the G6PD gene of 150 individuals

  3 years

Study Arms (1)

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.

Diagnostic Test: blood samples (venous and capillary at the fingertip)

Interventions

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

participants selected according to their G6PD activity

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Pasteur: lead
• Institut Pasteur de la Guyane: collaborator
• Centre Hospitalier Andrée Rosemon de Cayenne: collaborator

Study Sites (1)

Institut Pasteur de la Guyane

Cayenne, French Guiana

RECRUITING

MeSH Terms

Conditions

Malaria

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Lise Musset, PharmD

  Institut Pasteur de la Guyane, head of Parasitology laboratory

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Musset, PharmD

CONTACT

+335 94 29 68 40; lmusset@pasteur-cayenne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: January 7, 2021
• Study Start: May 5, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

FR (1)