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1. Neurologic manifestations associated with COVID-19: a multicentre registry

Author

Elodie Meppiel, Nathan Peiffer-Smadja, Alexandra Maury, Imen Bekri, Cécile Delorme, Virginie Desestret, Lucas Gorza, Geoffroy Hautecloque-Raysz, Sophie Landre, Annie Lannuzel, Solène Moulin, Peggy Perrin, Paul Petitgas, François SellaI, Adrien Wang, Pierre Tattevin, Thomas de Broucker, Sophie Abgrall, Fanny Alby-Laurent, Thibault Allou, Joséphine Amevigbe, Hanifa Amarguellay, Nabil Alloussi, Guillaume Baille, Mathilde Barbaz, Lamia Bencherif, Samia Bensaadi, Guillaume Beraud, Alexandra Bizot, Laure Bottin, Fabrice Bruneel, Jean-Philippe Camdessanche, Jeanne Chauffier, Jean-Philippe Csajaghy, Chloé De Broucker, Thomas De Broucker, Luc Defebvre, Elodie Dembloque, Nathalie Derache, Olivier Dereeper, Céline Derollez, Cécile Descotes-Genon, Mathilde Devaux, Lydie Dubuc, Gilles Edan, Andréa Fickl, Thibault Fraisse, Michel Gugenheim, Karolina Hankiewicz, Yves Hansmann, Carole Henry, Stéphanie Jobard, Fanny Jouan, Arnaud Kwiatkowski, Thibault Lalu, Johan Leguilloux, Camille Lejeune, Clémence Liegeois, Sophie Mahy, Jonathan Marey, Laure Michel, Rita Mitri, Chloé Moulin, Asma Omarjee, Canan Ozsancak, Fernando Pico, Marie Poupard, Valérie Rabier, Camille Rizzato, Caroline Roos, Julien Saison, Naomi Sayre, Nicolas Sedillot, François Sellal, Jérôme Servan, Caroline Storey, Laurent Suchet, Paul Tarteret, Mathilde Thiebaut, Claudia Vaduva, David Varlan, Virginie Zarrouk, Centre Hospitalier de Saint-Denis [Ile-de-France], Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Université Sorbonne Paris Nord, Centre Hospitalier de Versailles André Mignot (CHV), CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hospices Civils de Lyon (HCL), Hôpital Foch [Suresnes], Hôpitaux Civils de Colmar, Centre d'Investigation Clinique Antilles-Guyane (CIC - Antilles Guyane), CHU de Fort de France-Centre Hospitalier Andrée Rosemon [Cayenne, Guyane Française]-CHU Pointe-à-Pitre/Abymes [Guadeloupe] -Institut National de la Santé et de la Recherche Médicale (INSERM)-Université des Antilles et de la Guyane (UAG), Centre Hospitalier Universitaire de Reims (CHU Reims), Les Hôpitaux Universitaires de Strasbourg (HUS), CHU Pontchaillou [Rennes], Service de Neurologie [Hôpitaux Civils de Colmar], Hôpitaux Civils Colmar, Jonchère, Laurent, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and Université des Antilles et de la Guyane (UAG)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pointe-à-Pitre/Abymes [Guadeloupe] -CHU de Fort de France-Centre Hospitalier Andrée Rosemon [Cayenne, Guyane Française]

Subjects
Male, 0301 basic medicine, Microbiology (medical), Registry, medicine.medical_specialty, [SDV]Life Sciences [q-bio], 030106 microbiology, Encephalopathy, Nervous System, 03 medical and health sciences, 0302 clinical medicine, Interquartile range, Internal medicine, medicine, Humans, Registries, 030212 general & internal medicine, Pleocytosis, Aged, Retrospective Studies, medicine.diagnostic_test, SARS-CoV-2, business.industry, Mortality rate, Brain, COVID-19, Retrospective cohort study, Magnetic resonance imaging, General Medicine, Neurologic manifestations, Middle Aged, medicine.disease, Thrombosis, 3. Good health, [SDV] Life Sciences [q-bio], Infectious Diseases, Neurological manifestations, Female, Original Article, France, Nervous System Diseases, business, Encephalitis
Abstract

International audience; OBJECTIVES: To provide an overview of the spectrum, characteristics and outcomes of neurologic manifestations associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. METHODS: We conducted a single-centre retrospective study during the French coronavirus disease 2019 (COVID-19) epidemic in March-April 2020. All COVID-19 patients with de novo neurologic manifestations were eligible. RESULTS: We included 222 COVID-19 patients with neurologic manifestations from 46 centres in France. Median (interquartile range, IQR) age was 65 (53-72) years and 136 patients (61.3%) were male. COVID-19 was severe or critical in 102 patients (45.2%). The most common neurologic diseases were COVID-19-associated encephalopathy (67/222, 30.2%), acute ischaemic cerebrovascular syndrome (57/222, 25.7%), encephalitis (21/222, 9.5%) and Guillain-Barré syndrome (15/222, 6.8%). Neurologic manifestations appeared after the first COVID-19 symptoms with a median (IQR) delay of 6 (3-8) days in COVID-19-associated encephalopathy, 7 (5-10) days in encephalitis, 12 (7-18) days in acute ischaemic cerebrovascular syndrome and 18 (15-28) days in Guillain-Barré syndrome. Brain imaging was performed in 192 patients (86.5%), including 157 magnetic resonance imaging (70.7%). Among patients with acute ischaemic cerebrovascular syndrome, 13 (22.8%) of 57 had multiterritory ischaemic strokes, with large vessel thrombosis in 16 (28.1%) of 57. Brain magnetic resonance imaging of encephalitis patients showed heterogeneous acute nonvascular lesions in 14 (66.7%) of 21. Cerebrospinal fluid of 97 patients (43.7%) was analysed, with pleocytosis found in 18 patients (18.6%) and a positive SARS-CoV-2 PCR result in two patients with encephalitis. The median (IQR) follow-up was 24 (17-34) days with a high short-term mortality rate (28/222, 12.6%). CONCLUSIONS: Clinical spectrum and outcomes of neurologic manifestations associated with SARS-CoV-2 infection were broad and heterogeneous, suggesting different underlying pathogenic processes.

Published
2021

2. Discontinuing β-lactam treatment after 3 days for patients with community-acquired pneumonia in non-critical care wards (PTC): a double-blind, randomised, placebo-controlled, non-inferiority trial

Author

Aurélien Dinh, Jacques Ropers, Clara Duran, Benjamin Davido, Laurène Deconinck, Morgan Matt, Olivia Senard, Aurore Lagrange, Sabrina Makhloufi, Guillaume Mellon, Victoire de Lastours, Frédérique Bouchand, Emmanuel Mathieu, Jean-Emmanuel Kahn, Elisabeth Rouveix, Julie Grenet, Jennifer Dumoulin, Thierry Chinet, Marion Pépin, Véronique Delcey, Sylvain Diamantis, Daniel Benhamou, Virginie Vitrat, Marie-Christine Dombret, Bertrand Renaud, Christian Perronne, Yann-Erick Claessens, José Labarère, Jean-Pierre Bedos, Philippe Aegerter, Anne-Claude Crémieux, Julie ATTAL-BEHAR, Sébastien BEAUNE, Thierry CHINET, Tristan CUDENNEC, Marine DE LAROCHE, Albane DE THEZY, Jennifer DUMOULIN, Caroline DUPONT, Elise FERCOT, Violaine GIRAUT, Ségolène GREFFE, Julie GRENET, Caroline GUYOT, Jean-Emmanuel KAHN, Sylvie LABRUNE, Marie LACHATRE, Sophie MOULIAS, Charlotte NALINE, Marion PEPIN, Elisabeth ROUVEIX, Marine SAHUT-D'IZARN, Abel SEFSSAFI, Laurent TEILLET, Jean-Pierre BRU, Jacques GAILLAT, Vincent GAUTIER, Cécile JANSSEN, Leonardo PAGANI, Virginie VITRAT, Malika ABDERRAHMANE, Juliette CAMUSET, Catherine LEGALL, Pascale LONGUET-FLANDRES, Anne-Marie MENN, Victoire DE LASTOURS, Marie LECRONIER, Gwenolée PREVOST, Charles BURDET, Ouda DERRADJI, Lelia ESCAUT, Etienne HINGLAIS, Philippe LEBRAS, Edouard LEFEVRE, Mathilde NOAILLON, Pauline RABIER, Maurice RAPHAEL, Elina TEICHER, Christiane VERNY, Daniel VITTECOQ, Benjamin WYPLOSZ, Michèle BEN HAYOUN, Françoise BRUN-VEZINET, Enrique CASALINO, Christophe CHOQUET, Marie-Christine DOMBRET, Xavier DUVAL, Nadhira HOUHOU, Véronique JOLY, Xavier LESCURE, Manuela POGLIAGHI, Christophe RIOUX, Yazdan YAZDANPANAH, Elsa BARROS, Belinda BEGGA, Sébastien BOUKOBZA, Houria BOUREDJI, Imad CHOUAHI, Isabelle DELACROIX, Antoine FROISSART, Valérie GARRAIT, Elsa NGWEM, Catherine PHLIPPOTEAU, Sepehr SALEHABADI, Cécile TOPER, Florent VINAS, Marie AMSILLI, Olivier EPAULARD, Patricia PAVESE, Isabelle PIERRE, Jean-Paul STAHL, Jérôme AULAGNIER, Julie CELERIER, Roxana COJOCARIU, Emmanuel MATHIEU, Charlotte RACHLINE, Yoland SCHOINDRE, Thomas SENE, Christelle THIERRY, Caroline APARICIO, Véronique DELCEY, Amanda LOPES, Marjolaine MORGAND, Pierre SELLIER, Guy SIMONEAU, Catherine CHAKVETADZE, Sylvain DIAMANTIS, Arnaud GAUTHIER, Kaoutar JIDAR, Béatrice JOURDAIN, Jean-Francois BOITIAUX, Patrick DESCHAMPS, Edouard DEVAUD, Bruno PHILIPPE, Ruxandra-Oana CALIN, Tomasz CHROBOCZEK, Benjamin DAVIDO, Laurène DECONINCK, Pierre DE TRUCHIS, Aurore LAGRANGE, Sabrina MAKHLOUFI, Morgan MATT, Guillaume MELLON, Olivia SENARD, Daniel BENHAMOU, Claire CHAPUZET, Laure CHAUFFREY, Manuel ETIENNE, Luc-Marie JOLY, Bérengère OBSTOY, Mathieu SALAUN, Luc THIBERVILLE, Julie TILLON, Diane BOLLENS, Julie BOTTERO, Pauline CAMPA, Gäelle COSQUERIC, Bénédicte LEFEBVRE, Zineb OUAZENE, Jérôme PACANOWSKI, Dominique PATERON, Nadia VALIN, Caroline COMPAIN, Hugues CORDEL, Benoit DOUMENC, Elena FOIS, Nicolas GAMBIER, Marie-Aude KHUONG, Elisa PASQUALONI, and Marie POUPARD

Subjects
medicine.medical_specialty, education.field_of_study, business.industry, Pneumonia severity index, Incidence (epidemiology), Population, General Medicine, 030204 cardiovascular system & hematology, Amoxicillin, medicine.disease, Placebo, 03 medical and health sciences, Pneumonia, 0302 clinical medicine, Community-acquired pneumonia, Internal medicine, medicine, 030212 general & internal medicine, education, Adverse effect, business, medicine.drug
Abstract

Summary Background Shortening the duration of antibiotic therapy for patients admitted to hospital with community-acquired pneumonia should help reduce antibiotic consumption and thus bacterial resistance, adverse events, and related costs. We aimed to assess the need for an additional 5-day course of β-lactam therapy among patients with community-acquired pneumonia who were stable after 3 days of treatment. Methods We did this double-blind, randomised, placebo-controlled, non-inferiority trial (the Pneumonia Short Treatment [PTC]) in 16 centres in France. Adult patients (aged ≥18 years) admitted to hospital with moderately severe community-acquired pneumonia (defined as patients admitted to a non-critical care unit) and who met prespecified clinical stability criteria after 3 days of treatment with β-lactam therapy were randomly assigned (1:1) to receive β-lactam therapy (oral amoxicillin 1 g plus clavulanate 125 mg three times a day) or matched placebo for 5 extra days. Randomisation was done using a web-based system with permuted blocks with random sizes and stratified by randomisation site and Pneumonia Severity Index score. Participants, clinicians, and study staff were masked to treatment allocation. The primary outcome was cure 15 days after first antibiotic intake, defined by apyrexia (temperature ≤37·8°C), resolution or improvement of respiratory symptoms, and no additional antibiotic treatment for any cause. A non-inferiority margin of 10 percentage points was chosen. The primary outcome was assessed in all patients who were randomly assigned and received any treatment (intention-to-treat [ITT] population) and in all patients who received their assigned treatment (per-protocol population). Safety was assessed in the ITT population. This study is registered with ClinicalTrials.gov, NCT01963442, and is now complete. Findings Between Dec 19, 2013, and Feb 1, 2018, 706 patients were assessed for eligibility, and after 3 days of β-lactam treatment, 310 eligible patients were randomly assigned to receive either placebo (n=157) or β-lactam treatment (n=153). Seven patients withdrew consent before taking any study drug, five in the placebo group and two in the β-lactam group. In the ITT population, median age was 73·0 years (IQR 57·0–84·0) and 123 (41%) of 303 participants were female. In the ITT analysis, cure at day 15 occurred in 117 (77%) of 152 participants in the placebo group and 102 (68%) of 151 participants in the β-lactam group (between-group difference of 9·42%, 95% CI −0·38 to 20·04), indicating non-inferiority. In the per-protocol analysis, 113 (78%) of 145 participants in the placebo treatment group and 100 (68%) of 146 participants in the β-lactam treatment group were cured at day 15 (difference of 9·44% [95% CI −0·15 to 20·34]), indicating non-inferiority. Incidence of adverse events was similar between the treatment groups (22 [14%] of 152 in the placebo group and 29 [19%] of 151 in the β-lactam group). The most common adverse events were digestive disorders, reported in 17 (11%) of 152 patients in the placebo group and 28 (19%) of 151 patients in the β-lactam group. By day 30, three (2%) patients had died in the placebo group (one due to bacteraemia due to Staphylococcus aureus, one due to cardiogenic shock after acute pulmonary oedema, and one due to heart failure associated with acute renal failure) and two (1%) in the β-lactam group (due to pneumonia recurrence and possible acute pulmonary oedema). Interpretation Among patients admitted to hospital with community-acquired pneumonia who met clinical stability criteria, discontinuing β-lactam treatment after 3 days was non-inferior to 8 days of treatment. These findings could allow substantial reduction of antibiotic consumption. Funding French Ministry of Health.

Published
2021

3. Factors Associated with Treatment Failure in Moderately Severe Community-Acquired Pneumonia: A Secondary Analysis of a Randomized Clinical Trial

Author

Aurélien, Dinh, Clara, Duran, Jacques, Ropers, Frédérique, Bouchand, Benjamin, Davido, Laurène, Deconinck, Morgan, Matt, Olivia, Senard, Aurore, Lagrange, Guillaume, Mellon, Ruxandra, Calin, Sabrina, Makhloufi, Victoire, de Lastours, Emmanuel, Mathieu, Jean-Emmanuel, Kahn, Elisabeth, Rouveix, Julie, Grenet, Jennifer, Dumoulin, Thierry, Chinet, Marion, Pépin, Véronique, Delcey, Sylvain, Diamantis, Daniel, Benhamou, Virginie, Vitrat, Marie-Christine, Dombret, Didier, Guillemot, Bertrand, Renaud, Yann-Erick, Claessens, José, Labarère, Philippe, Aegerter, Jean-Pierre, Bedos, Anne-Claude, Crémieux, Marie, Poupard, Université Paris-Saclay, Service des Maladies Infectieuses et Tropicales [CHU Raymond Poincaré], Hôpital Raymond Poincaré [AP-HP], Epidémiologie et modélisation de la résistance aux antimicrobiens - Epidemiology and modelling of bacterial escape to antimicrobials (EMAE), Institut Pasteur [Paris] (IP), Unité de Recherche Clinique des hôpitaux Pitié-Salpêtrière – Charles Foix [CHU Pitié Salpêtrière] (URC PSL-CFX), CHU Charles Foix [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Direction de la Recherche Clinique et de l'Innovation [AP-HP] (DRCI), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Services de Maladies Infectieuses et Tropicales [CHU Bichat], AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Cité - UFR Médecine [Santé] (UPCité UFR Médecine), Université Paris Cité (UPCité), Grand Hôpital de l'Est Francilien (GHEF), Centre Hospitalier René Dubos [Pontoise], Hôpital Beaujon [AP-HP], Hôpital Foch [Suresnes], Service de médecine interne [CHU Ambroise Paré], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Ambroise Paré [AP-HP], Hôpital Ambroise Paré [AP-HP], Hôpital Lariboisière-Fernand-Widal [APHP], Centre Hospitalier de Melun (CHM), CHU Rouen, Normandie Université (NU), Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois], Service de médecine d'urgence [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Centre Hospitalier Princesse Grace, Centre Hospitalier Universitaire [Grenoble] (CHU), Université Grenoble Alpes (UGA), Vieillissement et Maladies chroniques : approches épidémiologique et de santé publique (VIMA), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Centre Hospitalier de Versailles André Mignot (CHV), Hopital Saint-Louis [AP-HP] (AP-HP), This study was supported by grant PHRC 2005AOM05031 from the French Ministry of Health and sponsored by grant PO50607 from the DRCI of Versailles., HAL UVSQ, Équipe, Centre d'investigation clinique Paris Est [CHU Pitié Salpêtrière] (CIC Paris-Est), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), UFR Médecine [Santé] - Université Paris Cité (UFR Médecine UPCité), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Pfizer, Ministère des Affaires Sociales et de la Santé: PO50607, Funding/Support: This study was supported by grant PHRC 2005AOM05031 from the French Ministry of Health and sponsored by grant PO50607 from the DRCI of Versailles., and Conflict of Interest Disclosures: Dr Crémieux reported receiving grants from the French Ministry of Health during the conduct of the study and from Pfizer outside the submitted work. No other disclosures were reported.

Subjects
Male, medicine.medical_specialty, Population, Placebo, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, law.invention, 03 medical and health sciences, 0302 clinical medicine, Community-acquired pneumonia, Randomized controlled trial, law, Risk Factors, Internal medicine, medicine, Humans, 030212 general & internal medicine, Treatment Failure, education, Aged, Original Investigation, Aged, 80 and over, Univariate analysis, education.field_of_study, Duration of Therapy, business.industry, Research, General Medicine, Odds ratio, Pneumonia, Middle Aged, medicine.disease, 3. Good health, Community-Acquired Infections, Hospitalization, Online Only, Infectious Diseases, 030228 respiratory system, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, [SDV.MHEP.PSR] Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Female, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Complication, business
Abstract

Key Points Question What are the risk factors for treatment failure in patients with community-acquired pneumonia (CAP) who reached clinical stability after 3 days of β-lactam treatment? Findings In this secondary analysis of a randomized clinical trial that included 291 adults, only male sex and age were associated with failure in the multivariable analysis. These results were independent of antibiotic treatment duration and biomarker levels. Meaning In this study, among patients with CAP who reached clinical stability after 3 days of antibiotic treatment, male sex and age were associated with higher risk of failure, suggesting that these factors should be taken in account in the treatment of patients with the condition., Importance Failure of treatment is the most serious complication in community-acquired pneumonia (CAP). Objective To assess the potential risk factors for treatment failure in clinically stable patients with CAP. Design, Setting, and Participants This secondary analysis assesses data from a randomized clinical trial on CAP (Pneumonia Short Treatment [PTC] trial) conducted from December 19, 2013, to February 1, 2018. Data analysis was performed from July 18, 2019, to February 15, 2020. Patients hospitalized at 1 of 16 centers in France for moderately severe CAP who were clinically stable at day 3 of antibiotic treatment were included in the PTC trial and analyzed in the per-protocol trial population. Interventions Patients were randomly assigned (1:1) on day 3 of antibiotic treatment to receive β-lactam (amoxicillin-clavulanate [1 g/125 mg] 3 times daily) or placebo for 5 extra days. Main Outcomes and Measures The main outcome was failure at 15 days after first antibiotic intake, defined as a temperature greater than 37.9 °C and/or absence of resolution or improvement of respiratory symptoms and/or additional antibiotic treatment for any cause. The association among demographic characteristics, baseline clinical and biological variables available (ie, at the first day of β-lactam treatment), and treatment failure at day 15 among the per-protocol trial population was assessed by univariate and multivariable logistic regressions. Results Overall, 310 patients were included in the study; this secondary analysis comprised 291 patients (174 [59.8%] male; mean [SD] age, 69.6 [18.5] years). The failure rate was 26.8%. Male sex (odds ratio [OR], 1.74; 95% CI, 1.01-3.07), age per year (OR, 1.03; 95% CI, 1.01-1.05), Pneumonia Severe Index score (OR, 1.01; 95% CI, 1.00-1.02), the presence of chronic lung disease (OR, 1.85; 95% CI, 1.03-3.30), and creatinine clearance (OR, 0.99; 95% CI, 0.98-1.00) were significantly associated with failure in the univariate analysis. When the Pneumonia Severe Index score was excluded to avoid collinearity with age and sex in the regression model, only male sex (OR, 1.92; 95% CI, 1.08-3.49) and age (OR, 1.02; 95% CI, 1.00-1.05) were associated with failure in the multivariable analysis. Conclusions and Relevance In this secondary analysis of a randomized clinical trial, among patients with CAP who reached clinical stability after 3 days of antibiotic treatment, only male sex and age were associated with higher risk of failure, independent of antibiotic treatment duration and biomarker levels. Another randomized clinical trial is needed to evaluate the impact of treatment duration in populations at higher risk for treatment failure., This secondary analysis of a randomized clinical trial assesses treatment failure risk factors in patients with community-acquired pneumonia who reached clinical stability after 3 days of β-lactam treatment.

Published
2021

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