Rotavirus and norovirus in children with severe diarrhea in Burkina Faso before rotavirus vaccine introduction.

Burkina Faso introduced rotavirus vaccine (RotaTeq) to the national immunization program in November 2013. This study describes the detection rates, clinical profiles, and molecular epidemiology of rotavirus and norovirus (NoV) infections among children <5 years hospitalized (n = 154) because of acute diarrhea in Ouagadougou, Burkina Faso, from December 2012 to November 2013, just before the start of vaccination. Overall, 44% and 23% of fecal samples were positive for rotavirus and NoV, respectively, most of them detected during the cold dry season (December-March). The predominant G/P combinations were G12P[8] (47%) and G6P[6] (30%). G2P[4] (n = 3), G12P[6] (n = 3), and G6P[8] (n = 1) were also detected. Nearly all (94%) successfully genotyped NoV strains belonged to genotype GII.4. The predominance of rotavirus and NoV was noteworthy in the age group ≤6 months, with 67% rotavirus and 22% NoV, respectively. Vomiting was significantly more common among rotavirus-infected children. To conclude, this study shows high detection rates of both rotavirus and NoV in children with severe diarrhea in Burkina Faso just before the introduction of rotavirus group A vaccination. The results can be used for estimating the impact of rotavirus group A vaccination, which started in the end of 2013. Furthermore, this study shows that the G6P[6] rotavirus strains emerging in Burkina Faso in 2010 is now established as a regionally important genotype.

[State of play of the regulation of clinical trials in Mali]. / Etat des lieux de la reglementation des essais cliniques au Mali.

OBJECTIVE: The objective was to take stock of the regulation of clinical trials in Mali. MATERIAL AND METHODS: This was a descriptive cross-sectional study carried out of the September 1 to December 15, 2019. It consisted of a literature search and a survey in research centers, ethics committees and regulatory structures in Mali. RESULTS: In 2019, there were 15 clinical trials authorized and conducted by three research centers, including 12 vaccines and 3 drugs trials all approved by an ethics committee. The legal framework for clinical trials is governed in Mali by two texts, one legislative and the other regulatory. They provide for the authorization, suspension or prohibition of biomedical research by the minister in charge of Health. The shortcomings identified relate to the low recovery and lack of evaluation of pharmacovigilance data, the scarcity of site inspections and especially the absence of a technical committee for regulatory evaluation of files at the Pharmacy and Medicines Department (DPM). CONCLUSION: The strengthening of the legal framework is, more than ever, necessary to ensure the protection of the rights, safety and well-being of research subjects in a context of increasing relocation of clinical trials to our countries.

OBJECTIF: L'objectif était de réaliser l'état des lieux de la réglementation des essais cliniques au Mali. MATÉRIEL ET MÉTHODES: Il s'agissait d'une étude transversale descriptive réalisée du 1er septembre au 15 décembre 2019. Elle a consisté en une recherche documentaire et une enquête de terrain dans les centres de recherche, les comités d'éthique et les structures règlementaires du Mali. RÉSULTATS: En 2019, il y a eu 15 essais cliniques autorisés et réalisés par trois centres de recherche, dont 12 vaccinaux et 3 médicamenteux tous approuvés par un comité d'éthique. Le cadre juridique des essais cliniques est régi au Mali par deux textes dont l'un législatif et l'autre réglementaire. Ils prévoient l'autorisation, la suspension ou l'interdiction de la recherche biomédicale par le ministre en charge de la santé. Les insuffisances recensées sont relatives à la faible remontée et au manque d'évaluation des données de pharmacovigilance, la rareté des inspections des sites et surtout l'absence de comité technique d'évaluation règlementaire des dossiers à la Direction de la Pharmacie et du Médicament (DPM). CONCLUSION: Le renforcement du cadre juridique est, plus que jamais, nécessaire pour assurer la protection des droits, la sécurité et le bien-être des sujets de recherche dans un contexte de délocalisation croissante des essais cliniques vers nos pays.