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Doravirine versus dolutegravir-based regimen in antiretroviral treatment-naive people living with HIV-1 (ANRS0392s ELDORADO): protocol for an international, open-label, randomised, non-inferiority, phase III trial

Por: Lhostellier · A. · Kouanfack · C. · Chazallon · C. · Wagner-Cardoso · S. · Eholie · S. P. · Banze · N. · Halue · G. · Capeau · J. · Delaugerre · C. · Moh · R. · Bonnet · F. · Mfeukeu Kuate · L. · Jaquet · A. · Perazzo · H. · Bernard · C. · Bastard · J.-P. · Goldwirt · L. · Vilquin · P. · N
Introduction

Increasing evidence suggests that dolutegravir (DTG), endorsed by the WHO since 2018 for first-line antiretroviral therapy (ART), is associated with significant weight gain and potentially also with cardiometabolic disorders. In an effort to expand therapeutic options for people living with HIV (PLHIV), the EvaLuating the non-inferiority of DORAvirine vs DOlutegravir trial aims to compare the virologic efficacy of doravirine (DOR) and DTG-based regimens and to assess their safety, including a focus on cardiometabolic effects.

Methods and analysis

This is an international, phase III, multicentre, open-label, non-inferiority, randomised trial that will enrol 610 ART-naïve PLHIV (HIV RNA≥1000 copies/mL at screening) across six countries (Brazil, Cameroon, France, Côte d’Ivoire, Mozambique and Thailand) spanning four continents. Key inclusion criteria include age ≥18 years, confirmed HIV-1 infection with plasma RNA levels ≥1000 copies/mL, indication for ART initiation and no prior ART exposure. Participants will be randomised in a 1:1 ratio to receive either DOR 100 mg once daily in combination with tenofovir disoproxil fumarate (TDF) (300 mg daily) plus lamivudine (3TC) (300 mg daily) or DTG (50 mg daily) in combination with TDF (300 mg once daily) plus either emtricitabine (FTC) (200 mg daily) or 3TC (300 mg daily). Randomisation will be stratified by screening HIV-1 RNA load (≤100 000 or >100 000 copies/mL) and by country. The primary outcome is virological efficacy, defined as the proportion of participants achieving HIV-1 RNA

Ethics and dissemination

Primary outcome results (week 48) are expected in early 2028. The project was submitted to and approved by national ethics committees and pharmaceutical regulatory authorities in all participating countries: Brazil (CEP INI FIOCRUZ (21.040-900)/CEP HGNI (26.030-380)); Cameroon (CNERSH (2024/09/1717/CE/CNERSH/SP)/Ministry of Public Health (D30-1464/AAR/MINSANTE/SG/DROS/CRC); Côte d'Ivoire: (CNESVS (0018224/MSHPCMU/CNESVS-km)/AIRP (1329/AIRP/DISMP/Om/kbaag); France (CTIS CPP/ANSM (2023-508626-10-00)); Mozambique (CNBS (20/CNBS/25)/ANARME (4635/380/ANARME)); Thailand: (IHRP (08/1944)/Thai FDA: ongoing on 19 January 2026). The trial received authorisation from the French National Commission for Data Protection and Liberties (CNIL) under approval number 924 302. Written informed consent is obtained from all participants prior to any study-specific procedures and trial enrolment, in accordance with the Declaration of Helsinki and applicable national regulations. Study findings will be disseminated through publication in peer-reviewed journals and presentations at national and international scientific conferences. Results will also be communicated to policymakers, healthcare professionals, community stakeholders and study participants through appropriate dissemination activities, including policy briefs, stakeholder meetings and lay summaries on dedicated and easily accessible platforms.

Trial registration numbers

NCT06203132; EU-CT, 2023-508626-10-00.

Lung and cardiac ultrasound for respiratory distress in the elderly: study protocol of the LUC REED stepped-wedge cluster randomised trial

Introduction

Dyspnea is a common chief complaint leading to emergency department (ED) visits. Multiple conditions may cause or be associated with dyspnoea, including bacterial pneumonia, acute heart failure (AHF), exacerbation of chronic obstructive pulmonary disease (COPD) or asthma and pulmonary embolism. Each of these diagnoses has a specific treatment recommended by international guidelines. Inappropriate treatment in the ED is more frequent among elderly patients and is independently associated with in-hospital mortality. Point-of-care ultrasound is immediately available at the bedside. Lung and cardiac ultrasound (LuCUS) offers excellent diagnostic accuracy for bacterial pneumonia, AHF and COPD exacerbations, even in elderly patients. The primary objective of the LUC REED trial is to evaluate the impact of a LuCUS-guided strategy versus standard care on reducing inappropriate treatment of dyspnoea in elderly ED patients.

Methods and analysis

The LUC REED trial is a prospective, interventional, multicentre, stepped-wedge randomised controlled trial designed to assess the superiority of a LuCUS-guided strategy over standard care in ensuring treatment appropriateness for dyspnoea in elderly ED patients. The study will include 504 patients over 2 years. Patients aged >65 years presenting with acute dyspnoea and signs of severity (respiratory rate ≥22 or SpO2

Ethics and dissemination

Ethics final approval was obtained from the Institutional Review Board of France—Est IV on 4 April 2025 (2024-A01678-39). Results will be published in peer-reviewed international journals.

Trial registration number

NCT06807983.

Impact of increased resident preparation time on internal medicine rounds in a tertiary teaching hospital: a time-motion study with a before-and-after comparison

Por: Garnier · A. · Cominetti · F. · Monti · M. · Marques-Vidal · P. · Bastardot · F. · Vollenweider · P. · Waeber · G. · Castioni · J. · Gachoud · D. · Kraege · V.
Objectives

To determine whether postponing daily medical rounds to provide additional preparation time for residents reduces round duration and alters time allocation during rounds, with the hypothesis that increased preparation leads to more efficient rounds without reducing patient contact.

Design

Time and motion study with a before-and-after comparison.

Setting

Internal medicine division of Lausanne University Hospital, a Swiss tertiary teaching hospital.

Participants

75 residents; 60% women; mean age of 29.6 years and 3.0 years of training.

Intervention

In 2017, the daily work schedule was reorganised by postponing rounds from 09:00 to 10:00 and moving educational sessions to the afternoon, thereby freeing 90 min to prepare patient cases before rounds.

Primary and secondary outcome measures

The primary outcome was the duration of rounds and the proportion thereof spent with patients, using computer systems or in discussion with colleagues. Secondary outcomes included the detailed distribution of resident activities during the officially scheduled round period, particularly time dedicated to supervision, teaching and administrative tasks.

Results

Round duration decreased from 142 min per shift (95% CI 128 to 156) in 2015 to 112 min (95% CI 101 to 124) in 2018 (p=0.001). The proportion of round time spent directly with patients remained stable at 47%. Computer use during rounds decreased from 43% to 32% (p

Conclusions

Postponing rounds to allow more preparation time was associated with shorter, possibly more efficient rounds, reduced computer use in patient presence and increased supervision and teaching.

Trial registration number

ISRCTN69703381, https://doi.org/10.1186/ISRCTN69703381 (registration date: 24 April 2018).

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