ABSTRACT
Introduction: The emergence or persistence of symptoms after acute SARS-CoV-2 infection has made it necessary to develop tools to detect them and assess their impact on patients' quality of life. One of these tools is the COVID-19 Yorkshire Rehabilitation Screening (C19-YRS) scale. We present the results of this tool in a cohort of first pandemic wave patients. Methods: A cross-sectional study of patients with confirmed SARS-CoV-2 infection from March to May 2020 in Lugo (northwestern Spain). C19-YRS was administered via phone 10 months after the acute infection to both former inpatients and outpatients. Electronic medical records were reviewed and relevant data from the acute episode were collected. The main outcome was the presence of impairment in different areas measured by the C19-YRS scale. Results: The answer rate was 63.2%. The mean age was 54 ± 16 years, 38.4% were male and 190 (42.9%) had some comorbidity. Eighty-seven patients (19.6%) required hospitalization and 10 (2.3%) required intensive care unit admission. Ten (3.5%) patients lost their job due to the pandemic. Two hundred seventy-six patients (62.3%) related any symptoms; fatigue (37.2%) and exertional dyspnea (33.4%) were the most common with significant worsening in both cases compared with the situation before the infection. Subgroup analysis showed that more symptom domains were impaired in women than men. Older patients, those with comorbidity and those who needed hospital admission, demanded more health resources after the acute infection. Discussion: C19-YRS is useful for the detection and quantification of symptoms after COVID-19 and provides relevant social, health, and occupational information.
ABSTRACT
INTRODUCTION: Methicillin-susceptible Staphylococcus aureus (MSSA) bacteraemia is a frequent condition, with high mortality rates. There is a growing interest in identifying new therapeutic regimens able to reduce therapeutic failure and mortality observed with the standard of care of beta-lactam monotherapy. In vitro and small-scale studies have found synergy between cloxacillin and fosfomycin against S. aureus. Our aim is to test the hypothesis that cloxacillin plus fosfomycin achieves higher treatment success than cloxacillin alone in patients with MSSA bacteraemia. METHODS: We will perform a superiority, randomised, open-label, phase IV-III, two-armed parallel group (1:1) clinical trial at 20 Spanish tertiary hospitals. Adults (≥18 years) with isolation of MSSA from at least one blood culture ≤72 hours before inclusion with evidence of infection, will be randomly allocated to receive either cloxacillin 2 g/4-hour intravenous plus fosfomycin 3 g/6-hour intravenous or cloxacillin 2 g/4-hour intravenous alone for 7 days. After the first week, sequential treatment and total duration of antibiotic therapy will be determined according to clinical criteria by the attending physician.Primary endpoints: (1) Treatment success at day 7, a composite endpoint comprising all the following criteria: patient alive, stable or with improved quick-Sequential Organ Failure Assessment score, afebrile and with negative blood cultures for MSSA at day 7. (2) Treatment success at test of cure (TOC) visit: patient alive and no isolation of MSSA in blood culture or at another sterile site from day 8 until TOC (12 weeks after randomisation).We assume a rate of treatment success of 74% in the cloxacillin group. Accepting alpha risk of 0.05 and beta risk of 0.2 in a two-sided test, 183 subjects will be required in each of the control and experimental groups to obtain statistically significant difference of 12% (considered clinically significant). ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Ethics Committee of Bellvitge University Hospital (AC069/18) and from the Spanish Medicines and Healthcare Product Regulatory Agency (AEMPS, AC069/18), and is valid for all participating centres under existing Spanish legislation. The results will be presented at international meetings and will be made available to patients and funders. TRIAL REGISTRATION NUMBER: The protocol has been approved by AEMPS with the Trial Registration Number EudraCT 2018-001207-37. ClinicalTrials.gov Identifier: NCT03959345; Pre-results.