Search

Introduction: Bamlanivimab and etesevimab (BAM + ETE) are monoclonal antibodies (mAbs) effective in reducing COVID-19-related hospitalizations and all-cause mortality in adult participants at increased risk for severe disease. We present pharmacokinetic (PK), efficacy, and safety results from pediatric participants (< 18 years of age) with COVID-19 who were treated with BAM + ETE. Methods: In an addendum to the phase 2/3 BLAZE-1 clinical trial (NCT04427501), pediatric participants received open-label weight-based dosing (WBD, n = 94) based on exposure-matching to the authorized dose of BAM + ETE in adult participants. For efficacy and safety assessments, placebo (n = 14) and BAM + ETE (n = 20)-treated adolescent participants (> 12 to < 18 years of age) from the BLAZE-1 trial were included in the overall pediatric population (N = 128). All participants had mild to moderate COVID-19 upon enrollment and ≥ 1 risk factor for severe COVID-19. The primary objective was to characterize the PK of BAM and ETE in the WBD population. Results: The median age of the participants was 11.2 years, 46.1% were female, 57.9% were Black/African American, and 19.7% were Hispanic/Latino. The area under the curve for BAM and ETE in the WBD population was similar to that previously observed in adults. There were no COVID-19-related hospitalizations or deaths. All adverse events (AE) except one were mild or moderate, with one participant reporting a serious AE. Conclusion: WBD in pediatric participants achieved similar drug exposures compared to adult participants that received the authorized BAM + ETE dose. The pediatric efficacy and safety data were consistent with adults receiving mAbs for COVID-19. Trial Registration Number: NCT04427501. [ABSTRACT FROM AUTHOR]

Background: Diagnosis and treatment of shoulder periprosthetic joint infection is a difficult problem. The purpose of this study was to utilize the 2018 International Consensus Meeting definition of shoulder periprosthetic joint infection to categorize revision shoulder arthroplasty cases and determine variations in clinical presentation by presumed infection classification. Methods: Retrospective review of patients undergoing revision shoulder arthroplasty at a single institution. Likelihood of periprosthetic joint infection was determined based on International Consensus Meeting scoring. All patients classified as definitive or probable periprosthetic joint infection were classified as periprosthetic joint infection. All patients classified as possible or unlikely periprosthetic joint infection were classified as aseptic. The periprosthetic joint infection cohort was subsequently divided into culture-negative, non-virulent microorganism, and virulent microorganism cohorts based on culture results. Results: Four hundred and sixty cases of revision shoulder arthroplasty were reviewed. Eighty (17.4%) patients were diagnosed as definite or probable periprosthetic joint infection, of which 29 (36.3%), 39 (48.8%), and 12 (15.0%) were classified as virulent, non-virulent, or culture-negative periprosthetic joint infection, respectively. There were significant differences among periprosthetic joint infection subgroups with regard to preoperative C-reactive protein (p = 0.020), erythrocyte sedimentation rate (p = 0.051), sinus tract presence (p = 0.008), and intraoperative purulence (p < 0.001). The total International Consensus Meeting criteria scores were also significantly different between the periprosthetic joint infection cohorts (p < 0.001). Discussion: While the diagnosis of shoulder periprosthetic joint infection has improved with the advent of International Consensus Meeting criteria, there remain distinct differences between periprosthetic joint infection classifications that warrant further investigation to determine the accurate diagnosis and optimal treatment. [ABSTRACT FROM AUTHOR]

Background: The coronavirus disease 2019 (COVID-19) course may be affected by environmental factors. Ecological studies previously suggested a link between climatological factors and COVID-19 fatality rates. However, individual-level impact of these factors has not been thoroughly evaluated yet., Aim: To study the association of climatological factors related to patient location with unfavorable outcomes in patients., Methods: In this observational analysis of the Society of Critical Care Medicine Discovery Viral Infection and Respiratory Illness Universal Study: COVID-19 Registry cohort, the latitudes and altitudes of hospitals were examined as a covariate for mortality within 28 d of admission and the length of hospital stay. Adjusting for baseline parameters and admission date, multivariable regression modeling was utilized. Generalized estimating equations were used to fit the models., Results: Twenty-two thousand one hundred eight patients from over 20 countries were evaluated. The median age was 62 (interquartile range: 49-74) years, and 54% of the included patients were males. The median age increased with increasing latitude as well as the frequency of comorbidities. Contrarily, the percentage of comorbidities was lower in elevated altitudes. Mortality within 28 d of hospital admission was found to be 25%. The median hospital-free days among all included patients was 20 d. Despite the significant linear relationship between mortality and hospital-free days (adjusted odds ratio (aOR) = 1.39 (1.04, 1.86), P = 0.025 for mortality within 28 d of admission; aOR = -1.47 (-2.60, -0.33), P = 0.011 for hospital-free days), suggesting that adverse patient outcomes were more common in locations further away from the Equator; the results were no longer significant when adjusted for baseline differences (aOR = 1.32 (1.00, 1.74), P = 0.051 for 28-day mortality; aOR = -1.07 (-2.13, -0.01), P = 0.050 for hospital-free days). When we looked at the altitude's effect, we discovered that it demonstrated a non-linear association with mortality within 28 d of hospital admission (aOR = 0.96 (0.62, 1.47), 1.04 (0.92, 1.19), 0.49 (0.22, 0.90), and 0.51 (0.27, 0.98), for the altitude points of 75 MASL, 125 MASL, 400 MASL, and 600 MASL, in comparison to the reference altitude of 148 m.a.s.l, respectively. P = 0.001). We detected an association between latitude and 28-day mortality as well as hospital-free days in this worldwide study. When the baseline features were taken into account, however, this did not stay significant., Conclusion: Our findings suggest that differences observed in previous epidemiological studies may be due to ecological fallacy rather than implying a causal relationship at the patient level., Competing Interests: Conflict-of-interest statement: None of the authors have any conflict of interest to disclose., (©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.)