Dramatic diminution of a large calcification treated with topical sodium thiosulfate.

International audienc

Ethical considerations of the dynamics of clinical trials in an epidemic context: Studies on COVID-19

International audienceThe COVID-19 epidemic has led to the intense mobilization of all health professionals, including those involved in research. From the very beginning, research ethics committees (RECs) have been called upon and mobilized to carry out the scientific and ethical evaluations of research projects to achieve a sound analysis of their risk/benefit balance. The aim of this article is to present an ethical reflection on the challenges and consequences of the fast-track procedure for the evaluation of COVID-19 research projects in the context of a public health emergency. Indeed, a large number of protocols of reduced rigor were hastily prepared without collaboration between researchers and in the absence of national regulation. As a result, a number of ethical dilemmas have emerged concerning the opposing needs of pragmatism imposed by the emergency context and the ethical principles that should govern the conduct of research. Moreover, the dispersion of these individual projects, aggravated by excessive media coverage of specific treatments, has resulted in a weakened impact of the research in the epidemic context. This article provides suggestions for the ethical management of ongoing and upcoming research, giving RECs the opportunity to adapt their evaluations to avoid allowing the pragmatism of the emergency context to subvert the inviolability of the epistemological and ethical principles of research on humans. This reflection may strengthen the ethical basis for the formulation of their decisions

Moving from bag to catheter for urine collection in non-toilet-trained children suspected of having urinary tract infection: a paired comparison of urine cultures.

International audienceOBJECTIVE: To compare, in the same children, urine culture results from bag- versus catheter-obtained specimens with catheter culture as the reference. STUDY DESIGN: A total of 192 non-toilet-trained children <3 years of age from 2 emergency departments were recruited for this prospective cross-sectional study. All had positive urinalysis results from bag-obtained specimens that were systematically checked with a catheter-obtained specimen before treatment. Results of comparison of urine cultures obtained with these 2 collecting methods are presented. RESULTS: A total of 7.5% of bag-obtained specimen positive cultures had false-positive results. Twenty-nine percent of bag-obtained specimen cultures with negative results were false negative. Altogether, bag-obtained specimens led to either a misdiagnosis or an impossible diagnosis in 40% of cases versus 5.7% when urethral catheterization was used. CONCLUSION: Every bag-obtained positive-result urinalysis should be confirmed with a more reliable method before therapy

Topical Sodium Thiosulfate: A Treatment for Calcifications in Hyperphosphatemic Familial Tumoral Calcinosis?

International audienc

Pain experienced by infants and toddlers at urine collection bag removal: A randomized, controlled, clinical trial

International audienceBACKGROUND:In pre-continent children, collection bags are frequently used as a first-line option to obtain a urine specimen. This practice, acknowledged by several guidelines for the step of UTI screening, is driven by a perception of the technique as being more convenient and less painful. However, our own experience led us to consider bag removal as a painful experience.OBJECTIVE:Our aim was to determine whether the use of an oleo-calcareous liniment to aid bag removal reduced the acute pain expressed by young children.METHODS:This prospective, randomized, controlled, single blind study was carried out in two emergency pediatrics departments. Pre-continent children aged 0-36 months admitted with an indication for urine testing were eligible for the study. Urine for dipstick test screening was obtained using a collection bag. At micturition, the patients were randomized into bag removal with (intervention group) or without (control group) liniment. Bag removal was recorded on video in such a manner as to permit independent assessments of pain by two evaluators blinded to group allocation. Pain was assessed using the FLACC scale.FINDINGS:135 patients were analyzed: 70 in the intervention group and 65 in the control group. The median FLACC scores [interquartile range] for the intervention and control groups, respectively 4.0 [2.0-7.0] and 4.0 [3.0-7.0], did not differ significantly (p = 0.5). A FLACC score ≥4 was obtained for 56% of the patients and a score ≥7 for 28%.CONCLUSION:Removal of urine collection bags caused moderate to severe pain in half of the children included. The use of an oleo-calcareous liniment did not reduce this induced pain

Table_1_Antibiotic Resistance Acquisition in the First Week of Life.XLSX

<p>Objectives: The fetus is considered sterile but recent studies have suggested that gut colonization could start before birth. Scarce data are available for the acquisition of resistant Gram-negative bacteria (GNB) during the first days of life. Several studies have shown that integrons play a major role in antibiotic resistance acquisition. In this work, we studied the dynamics of human intestinal acquisition of GNB and integrons during the first days of life.</p><p>Methods: Meconium was collected at birth and a stool sample before hospital discharge (days 2 or 3) on 185 term neonates. GNB were searched by culture on each sample and class 1, 2, and 3 integrons from each GNB or directly from samples. Eight risk factors for integron and GNB acquisition were studied.</p><p>Results: We isolated 228 GNB, 46 from meconium and the remainder from stools. No link was found between GNB isolation and antibiotic exposure during delivery, but antibiotic exposure during labor significantly selected bla_TEM-positive amoxicillin-resistant Enterobacteria. Two-thirds of GNB were antibiotic-susceptible and most of the resistant isolates were acquired after birth. Integrons were detected in 18 of the 228 GNB isolates from 3 meconium and 20 stools. Antibiotic administration during delivery and vaginal carriage of Streptococcus agalactiae appeared as risk factors for integron acquisition.</p><p>Conclusion: Gram-negative bacteria and integrons are mostly acquired after birth during the first days of life even if for some term neonates, meconium was not sterile. Antibiotic administration during delivery is a major risk for integron acquisition and for selection of amoxicillin-resistant Enterobacteria.</p

Data Monitoring Committees and clinical trials: from scientific justification to organisation

International audienc

Comité de surveillance indépendant dans les essais cliniques : de la justification scientifique à l’organisation

National audienceLes essais cliniques durent souvent plusieurs mois voire années. Au fur et à mesure de l’avancée l’essai, il peut être tentant s’assurer que les données accumulées ne permettent pas déjà répondre la question posée par l’essai ainsi arrêter précocement inclusions ou le suivi. Mais façon contre-productive, connaissance prise en compte résultats intermédiaires peuvent, dans certaines conditions, compromettre l’intégrité des résultats. C’est pour limiter ce risque – assurer une fiable évaluation thérapeutiques cette surveillance critères sécurité et|ou d’efficacité cours d’étude est confiée un comité indépendant. A partir qui leur sont transmis confidentielle, indépendant évalue balance du bénéfice-risque traitement l’étude établit recommandation quant poursuite, modification l’arrêt l’étude. travers ces recommandations, membres comités ont responsabilité importante : décision d’arrêt trop hâtive rendre non concluant infructueux initiale au contraire, tardive exposer participants interventions potentiellement inefficaces nocives. La mission aux donc particulièrement complexe. Dans contexte, table ronde ateliers Giens a été l’occasion revenir sur justification scientifique vis-à-vis l’organisation indépendants rappeler nécessite d’être parfaitement formés problématiques inerrantes analyses multiples, l’obligation confidentialité fait recommandations doivent reposer suffisamment convaincantes évaluer étudié