PA-830 Study of biological reference values in the research sites at the Abdou Moumouni University, Niger

Résumé fourni par la source

Background The West the African Network of clinical trial of anti-malarial drug (WANECAM-II) is building a new clinical study team in Niger. There are no country-specific normal ranges for haematology and biochemistry parameters which are required for biological safety assessments in local trial participants. In preparation for upcoming Phase III trials of antimalarial drugs the aim this study was to determine the references values of biological parameters in Niger population and establish ranges of normal reference values for basic biochemical parameters and haematological parameters in the different seasons of the year. Methods A first cross sectional studies was conducted from September to October 2021 (rainy season) and a second from March to May 2022 (dry season). Venous blood was drawn from consenting participants in appropriate tubes for haematology and biochemistry parameters assessment. Parameters were analysed in three ages groups (3months- to 5 years, 6–14 years and 15–50 years) to refine the laboratory ranges by age-groups and by gender. Data were entered through Redcap, extracted, and analysed by RStudio. A Protocol specific training provided to the investigators before running the study. New calibrated Cobas c311 analyser for biochemistry and SYSMEX for haematology were provided to the team. Results We enrolled 533 and 519 volunteers with 65.3% and 33.9% male for the first and second cross-sectional respectively. The age group of 15–50 years was most represented with 48.9% in both seasons while the two other groups were at 25% each. The median values of each parameter, the Lower and Upper normal Limit were determined, and a references document for haematology and biochemistry parameters for clinical study purpose was generated. Detailed results will be presented at the Forum. Conclusion Through these two cross-sectional studies, we established the first biological parameters for safety evaluation ready to be used for the EDCTP-WANECAM-II KALUMA study in Niger.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.