NCT04698980

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Institut Pasteur · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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

Timeline

• Start date: 2021-05-05
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-01-07
• Last updated: 2022-11-09

Locations

1 site across 1 country: French Guiana