Chapitre 2. L'autonomisation des comités nationaux d'éthique de la recherche en Afrique : perspective historique et enjeux actuels.

Since the 60s, and particularly after various scandals in the 90s, national research ethics committees in Africa have established themselves as key players in the field of international clinical research. Notably based on the principle of double ethical review, their existence has historically been aimed at preventing a form of ethical dumping, a temptation that still exists today on the part of some research promoters. While the international framework of “soft” law has favored their emergence and legitimacy, a legal and regulatory framework of “hard” law is also necessary at local level for each national research ethics committee, to ensure its proper functioning and the optimal fulfillment of its missions. The aim of this article is to analyze the similarities and differences between three national ethics committees in Africa, specifically the CNERS of Guinea, the CNERS of Benin and the CNESVS of Côte d’Ivoire, in terms of status, missions, legal or regulatory ground and, more generally, autonomy. This analysis will enable us, on the one hand, to take account of common logistical difficulties and, on the other, to go beyond differences in legal status and missions to define what enables this type of committee to fully exercise its role(s). Finally, this article proposes to model the various elements that contribute to the autonomy and resilience of a national research ethics committee, around a notion proposed on this occasion: the “circles of autonomy”.

Dermatoses in international travellers seen at Bordeaux teaching hospital travel clinic, 2015-2018: a GeoSentinel-based study.

Skin disorders are frequent in travellers, but data vary between different studies. The objectives of the current study were to describe imported dermatoses in the Bordeaux GeoSentinel prospective database between August 2015 and March 2018. During the study period, 1025 travellers were seen in the clinic, 201 of them with dermatoses. Patients with skin disorders were more likely to be aged > 60 years (OR = 1.88, 95% CI 1.22-2.89), to be tourists (OR 3.04, 95% CI 2.03-4.55) and to have travelled to South America (OR = 2.18, 95% CI 1.29-3.67), and less likely to have sought pretravel advice (OR = 0.53, 95% CI 0.31-0.91). Skin bacterial infections (19.4%) and Zika virus infections (18.4%) were the most common dermatoses. Dengue fever and bacterial skin infections were the leading causes of hospitalization. The contribution of tropical diseases to imported dermatoses remains important. Lack of pretravel advice puts tourists at risk of significant diseases such as dengue fever, Zika virus and bacterial infections.

Infectious events and associated risk factors in mycosis fungoides/Sézary syndrome: a retrospective cohort study.

BACKGROUND: Infections are one of the major causes of death in patients with advanced-stage mycosis fungoides (MF) or Sézary syndrome (SS). However, few recent data are available on the characteristics and risk factors of these infectious events. OBJECTIVES: To describe infectious events occurring in a cohort of patients with MF/SS, and to identify associated clinical and biological risk factors. METHODS: A retrospective cohort study was performed to investigate infectious events and associated factors in patients diagnosed with MF (stage IB and beyond) or SS followed from May 2011 to May 2016 at the University Hospital of Bordeaux, France. RESULTS: Seventy-one patients with complete follow-up were included. Eighty infectious events were recorded in 40 patients, including 28 skin and soft tissue infections and 25 cases of pneumonia. Opportunistic infections, which are usually associated with depleted cell-mediated immunity, were scarce (9%). In multivariate analysis, cardiac, renal or lung comorbidities [odds ratio (OR) 7·2, 95% confidence interval (CI) 3·3-15·9; P = 0·002], SS (OR 8·8, 95% CI 7·7-10·2; P = 0·037) and lymphocyte count < 0·5 × 109 cells L-1 (OR 6·4, 95% CI 1·5-27·4; P = 0·004) were significantly associated with a higher risk of infection. CONCLUSIONS: Opportunistic germs were rarely recorded, but their incidence was probably prevented by adequate prophylaxis (ongoing in 28% of patients). As in patients living with AIDS, pneumonias were frequent. On the other hand, bacterial cutaneous infections represent a specific pattern in patients with MF/SS. Patients with chronic organ failure, lymphocytopenia and SS should be considered as being at high risk for infectious events. Pneumococcal vaccination should be systematically recommended, and prophylaxis with co-trimoxazole and valaciclovir when the CD4 count is < 0·2 × 109 cells L-1 .

Screening for active tuberculosis before isoniazid preventive therapy among HIV-infected West African adults.

SETTING: TEMPRANO was a multicentre, open-label trial in which human immunodeficiency virus (HIV) infected adults with high CD4 counts were randomised into early or deferred antiretroviral therapy (ART) arms with or without 6-month isoniazid preventive therapy (IPT) in a setting where the World Health Organization (WHO) recommends IPT in HIV-infected patients. Despite the WHO recommendation, IPT coverage remains low due to fear of the presence of undiagnosed active TB before prescribing IPT, and the related risk of drug resistance. OBJECTIVE: To report the frequency of undiagnosed TB in patients enrolled for IPT and describe the results of a 1-month buffer period to avoid prescribing IPT for active TB cases. DESIGN: Patients were screened using a clinical algorithm and chest X-ray at Day 0 and started on isoniazid at Month 1 if no sign/symptom suggestive of TB appeared between Day 0 and Month 1. RESULTS: Of 1030 patients randomised into IPT arms. 10% never started IPT at Month 1. Of these, 23 had active TB, including 16 with prevalent TB. Among the 927 patients who started IPT, 6 had active TB, including 1 with prevalent TB. Only 1 patient with active TB received IPT due to the 1-month buffer period between Day 0 and IPT initiation. CONCLUSION: In this study, 1.6% of adults considered free of active TB based on clinical screening at pre-inclusion actually had active TB.