0000000000441101
AUTHOR
Catherine Cornu
Essais cliniques institutionnels : quel monitoring ?
Resume Objectif Les promoteurs assument la responsabilite de la qualite des essais cliniques. Ces methodes d’assurance qualite doivent etre les plus efficaces possible, et avoir un cout maitrise. Nous voulions decrire les erreurs les plus frequentes, a partir de la litterature, leur impact sur les resultats, et proposer les strategies de monitoring les plus efficientes. Resultats Les defauts rencontres concernent la conception, les procedures, la gestion des donnees et l’analyse. L’impact sur les resultats est presque toujours une surestimation de l’effet traitement. Aucune methode de monitoring n’ayant ete demontree superieure, un monitoring econome, cible sur les risques d’erreurs, avec d…
Factors associated with 12 week case-fatality in Staphylococcus aureus bacteraemia: a prospective cohort study
International audience; Staphylococcus aureus bacteraemia (SAB) is a frequent and deadly disease. Given the lack of a randomized trial, optimal first-line antibiotic treatment is still debated. Our aim was to identify prognostic factors in SAB patients and to analyse the impact of first-line antibiotics. The VIRSTA prospective cohort study was conducted in eight tertiary care centres in France. Consecutive incident adults in whom a blood culture drawn in participating centres grew S. aureus between April 2009 and October 2011 were prospectively followed for 12 weeks. Factors associated with 12-week case-fatality were identified by multivariate logistic regression. We enrolled 2091 patients …
Manuel de bonnes pratiques professionnelles des centres d’investigation clinique
Resume Les centres d’investigation clinique (CIC) sont des structures de recherche clinique academiques appartenant a un reseau national, coordonne par l’Institut national de la sante et de la recherche medicale (Inserm) et la Direction generale de l’offre de soins (DGOS), comportant des groupes de travail et des reseaux thematiques. Le groupe « Harmonisation des procedures des CIC » (HPCIC) a elabore un manuel de bonnes pratiques professionnelles, presente dans cet article. Le manuel a ete elabore par consensus, relu par les coordonnateurs des CIC, des experts externes, et valide par des representants des deux tutelles Inserm et DGOS. Le manuel de bonnes pratiques professionnelles des CIC …
Ophthalmic Outcomes of Congenital Toxoplasmosis Followed Until Adolescence
BACKGROUND: Congenital toxoplasmosis (CT) can elicit severe damage to several organs, especially the eye, and may be manifested at birth or later. We assessed the long-term ocular prognosis in a cohort of congenitally infected children treated according to a standardized protocol and monitored for up to 22 years. METHODS: This prospective study included confirmed cases of CT, which were identified by obligatory antenatal screening at the Lyon (France) reference center between 1987 and 2008. Data obtained through ocular examinations were recorded on a standardized form and confirmed by an independent external committee. Risk factors for retinochoroiditis were identified by using a multivari…
Congenital \textittoxoplasma infection: monthly prenatal screening decreases transmission rate and improves clinical outcome at age 3 years
Background. Toxoplasma infection during pregnancy exposes the fetus to risks of congenital infection and sequelae that depend heavily on gestational age (GA) at time of infection. Accurate risk estimates by GA are necessary to counsel parents and improve clinical decisions. Methods. We analyzed data from pregnant women diagnosed with acute Toxoplasma infection in Lyon (France) from 1987 to 2008 and assessed how the risks of congenital toxoplasmosis and of clinical signs at age 3 years vary depending on GA at the time of maternal infection. Results. Among 2048 mother-infant pairs, 93.2% of mothers received prenatal treatment and 513 (24.7%) fetuses were infected. Because of a significant red…
Time to blood culture positivity: An independent predictor of infective endocarditis and mortality in patients with Staphylococcus aureus bacteraemia
International audience; Objectives - Time to blood culture positivity (TTP), a routinely available parameter in automated blood culture systems, may be a proxy for infectious burden in patients with bloodstream infections. We aimed to study the association between TTP and infective endocarditis (IE), or death, in patients with Staphylococcus aureus bacteraemia. Methods - VIRSTA is a multicenter prospective cohort study that included all adult patients with S. aureus bacteraemia in eight university hospitals in France (2009-2011). We analyzed data from four centers which collected data on TTP. Regression models were used to study the association between TTP and definite IE (Duke-Li criteria)…