Paracetamol Concentrations and Time-Course of Ductus Arteriosus Diameter in Extremely Preterm Neonates: A Population Pharmacokinetic-Pharmacodynamic Analysis.

Background: Patent ductus arteriosus is a common complication of extreme prematurity. Prophylactic treatment with indomethacin or ibuprofen has shown efficacy on ductus closure but without reducing mortality and morbidity. Prophylactic treatment by paracetamol could be a safer alternative.

Clinical research in rapid sequence during a pandemic: Lessons learned and the way forward.

Following COVID-19 pandemic, the structuring of a national research network for the preparation and response to emerging infectious diseases (EID) with epidemic or pandemic potential is essential. The national operational research network for EID, OPEN-ReMIE is funded for five years by the program France 2030 and operated by the National Research Agency (ANR). Its primary mission is to accelerate hospital-based clinical research with academic or industrial sponsors under epidemic or pandemic conditions and lead this effort within international research networks.

Experience and lessons learned relating to investigational product supply in the design and delivery of a paediatric investigator-initiated clinical trial.

The management of investigational product (IP) supply is a complex endeavour when designing and delivering clinical trials. In contrast to industry-sponsored trials where IP supplies are coordinated by teams of specialists working together throughout the entire supply chain, investigator initiated clinical trials often face IP-related challenges that can result in substantial trial delays, higher costs, and even early termination of the trial. Despite the challenges faced by investigators, there has been relatively few discussions on this topic in the literature.

Implementation of an Online Drug-Drug Interaction Screener for the STRIVE Ensitrelvir Trial for COVID-19.

Background: Ensitrelvir is an antiviral agent against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with associated drug-drug interactions (DDIs) through CYP3A, -glycoprotein (-gp), breast cancer resistance protein (BCRP), and organic anion transporter-3 (OAT-3) inhibition. We present the development and implementation of an online DDI screener to assess interactions during the STRIVE ensitrelvir trial.

Methods: The STRIVE Network is conducting a randomized, double-blind, placebo-controlled trial evaluating ensitrelvir's efficacy and safety in hospitalized adults with coronavirus disease 2019 (COVID-19) and lower respiratory tract involvement.

Prediction of cardiovascular events by skin auto-fluorescence: the DIABAGE follow-up study.

Aim: Advanced glycation end-products (AGEs) are known to play a role in the pathophysiology of type 1 diabetes (T1D) complications. The aim of this study was to assess the predictive value of AGEs indirectly evaluated by skin auto-fluorescence (SAF) on the occurrence of cardiovascular events (CVEs) in T1D.

Methods: We measured baseline SAF in T1D patients with at least 10 years history of diabetes and assessed incident CVEs.

Effects of Janus kinase inhibitors in adults admitted to hospital due to COVID-19: a systematic review and individual participant data meta-analysis of randomised clinical trials.

Background: Evidence from randomised clinical trials (RCTs) of Janus kinase (JAK) inhibitors-compared with usual care or placebo-in adults treated in hospital for COVID-19 is conflicting. We aimed to evaluate the benefits and harms of JAK inhibitors compared with placebo or usual care and whether treatment effects differed between prespecified participant subgroups.

Methods: For this systematic review and individual participant data meta-analysis (IPDMA), we searched Medline via Ovid, Embase via Elsevier, the Cochrane Central Register of Controlled Trials, the Cochrane COVID-19 Study Register, and the COVID-19 L·OVE Platform, including backward and forward citation searching (last search Nov 28, 2024), for RCTs (unpublished or published in any format and any language) that randomly assigned adults (aged ≥16 years) admitted to a hospital due to COVID-19 to receive either a JAK inhibitor (any type) or no JAK inhibitor (ie, received site-specific standard of care with or without placebo), and requested individual participant data (IPD) from the original trial teams.

sST2 is a key outcome biomarker in COVID-19: insights from discovery randomized trial.

We investigated whether baseline levels of biomarkers related to endotheliopathy, thromboinflammation, and fibrosis were associated with clinical outcomes in hospitalized COVID-19 patients. We analyzed the associations between baseline levels of 21 biomarkers and time to hospital discharge and change in NEWS-2 score in patients from DisCoVeRy trial. We fitted multivariate models adjusted for baseline ISARIC 4C score, disease severity, D-dimer values, and treatment regimen.

Delayed Neurological Sequelae of Carbon Monoxide Intoxication Initially Treated as Infectious Meningo Encephalitis.

Unlabelled: We report the case of a 75-year-old woman admitted to the emergency department for confusion, gait disturbances and mutism associated with an inflammatory syndrome occurring 3 weeks after acute carbon monoxide intoxication. The main hypothesis upon arrival was infectious meningoencephalitis, and the patient was put on acyclovir and antibiotics in meningeal doses. After a short stay in intensive care, the patient's condition did not improve, and the revaluation of her case history and imaging studies led to the diagnosis of post-interval syndrome secondary to carbon monoxide intoxication after a 3-week asymptomatic period.

TREOCAPA: prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophen-statistical analysis plan for the randomized phase III group sequential trial.

Background: Persistent patency of the ductus arteriosus (PDA) has challenged neonatologists for more than 40 years. Controversies persist about the management of PDA in extremely preterm infants. PDA is associated with morbidities, but no therapeutic strategy has resulted in an improved neonatal outcome.

Vaccination strategies for Ebola in the democratic republic of Congo: the WHO-Ebola modeling collaboration.

Objectives: Assess the effectiveness of ring vaccination in controlling an Ebola virus outbreak in the Democratic Republic of Congo.

Methods: This analysis focuses on two areas of the Democratic Republic of Congo, Beni and Butembo/Katwa, which were affected during the 2018-2020 Ebola outbreak. To simulate Ebola virus transmission, we used a spatially explicit agent-based model with households, health care facilities, and Ebola treatment units.

Safety of baricitinib in vaccinated patients with severe and critical COVID-19 sub study of the randomised Bari-SolidAct trial.

Background: The Bari-SolidAct randomized controlled trial compared baricitinib with placebo in patients with severe COVID-19. A post hoc analysis revealed a higher incidence of serious adverse events (SAEs) among SARS-CoV-2-vaccinated participants who had received baricitinib. This sub-study aimed to investigate whether vaccination influences the safety profile of baricitinib in patients with severe COVID-19.

Safety and immunogenicity of CD40.HIVRI.Env, a dendritic cell-based HIV vaccine, in healthy HIV-uninfected adults: a first-in-human randomized, placebo-controlled, dose-escalation study (ANRS VRI06).

Background: Current HIV prophylactic vaccines evaluate HIV Env as purified proteins. CD40.HIVRI.

Baseline characteristics for phase II of the Kinshasa Malaria Cohort Study: cohort profile.

Purpose: The Democratic Republic of Congo has one of the highest burdens of malaria in the world, accounting for 12.3% of malaria cases and 11.6% of malaria deaths.

Monovalent rotavirus vaccine effectiveness and long-term impact among children <5 years old in Antananarivo, Madagascar, 2010-2022.

Background: Monovalent rotavirus vaccine substantially reduced rotavirus disease burden after introduction (May 2014) in Madagascar. We examined the effectiveness and long-term impact on acute watery diarrhea and rotavirus-related hospitalizations among children <5 years old at two hospitals in Antananarivo, Madagascar (2010-2022).

Methods: We used a test-negative case-control design to estimate monovalent rotavirus vaccine effectiveness (VE) against laboratory-confirmed rotavirus hospitalizations among children age 6-23 months with documented vaccination status adjusted for year of symptom onset, rotavirus season, age group, nutritional status, and clinical severity.

Feasibility, safety, efficacy and potential scaling-up of sofosbuvir-based HCV treatment in Central and West Africa: (TAC ANRS 12311 trial).

Access to Hepatis C treatment in Sub-Saharan Africa is a clinical, public health and ethical concern. The multi-country open-label trial TAC ANRS 12311 allowed assessing the feasibility, safety, efficacy of a specific care model of HCV treatment and retreatment in patients with hepatitis C in Sub Saharan Africa. Between November 2015 and March 2017, with follow-up until mid 2019, treatment-naïve patients with HCV without decompensated cirrhosis or liver cancer were recruited to receive 12 week-treatment with either sofosbuvir + ribavirin (HCV genotype 2) or sofosbuvir + ledipasvir (genotype 1 or 4) and retreatment with sofosbuvir + velpatasvir + voxilaprevir in case of virological failure.

Cardiac Adverse Events and Remdesivir in Hospitalized Patients With COVID-19: A Post Hoc Safety Analysis of the Randomized DisCoVeRy Trial.

Background: We aimed to evaluate the cardiac adverse events (AEs) in hospitalized patients with coronavirus disease 2019 (COVID-19) who received remdesivir plus standard of care (SoC) compared with SoC alone (control), as an association was noted in some cohort studies and disproportionality analyses of safety databases.

Methods: This post hoc safety analysis is based on data from the multicenter, randomized, open-label, controlled DisCoVeRy trial in hospitalized patients with COVID-19. Any first AE that occurred between randomization and day 29 in the modified intention-to-treat (mITT) population randomized to either remdesivir or control group was considered.

Predictors of severity and prolonged hospital stay of viral acute respiratory infections (ARI) among children under five years in Burkina Faso, 2016-2019.

Background: Viruses are the leading etiology of acute respiratory infections (ARI) in children. However, there is limited knowledge on drivers of severe acute respiratory infection (SARI) cases involving viruses. We aimed to identify factors associated with severity and prolonged hospitalization of viral SARI among children < 5 years in Burkina Faso.

Comparative evolutionary analyses of peste des petits ruminants virus genetic lineages.

Peste des petits ruminants virus (PPRV) causes a highly infectious disease affecting mainly goats and sheep in large parts of Africa, Asia, and the Middle East and has an important impact on the global economy and food security. Full genome sequencing of PPRV strains has proved to be critical to increasing our understanding of PPR epidemiology and to inform the ongoing global efforts for its eradication. However, the number of full PPRV genomes published is still limited and with a heavy bias towards recent samples and genetic Lineage IV (LIV), which is only one of the four existing PPRV lineages.

Prophylactic Intravenous Acetaminophen in Extremely Premature Infants: Minimum Effective Dose Research by Bayesian Approach.

Background: Patent ductus arteriosus (PDA) in preterm infants is associated with increased morbidities and mortality. Prophylactic treatment with cyclooxygenase inhibitors, as indomethacin or ibuprofen, failed to demonstrate significant clinical benefits. Acetaminophen may represent an alternative treatment option.