Carlos Ortega

BACKGROUND: Andes virus (ANDV)-related hantavirus cardiopulmonary syndrome (HCPS) has a 35% case fatality rate in Chile and no specific treatment. In an immunomodulatory approach, we evaluated the efficacy of intravenous methylprednisolone for HCPS treatment, through a parallel-group, placebo-controlled clinical trial. METHODS: Patients aged >2 years, with confirmed or suspected HCPS in cardiopulmonary stage, admitted to any of 13 study sites in Chile, were randomized by study center in blocks of 4 with a 1:1 allocation and assigned through sequentially numbered envelopes to receive placebo or methylprednisolone 16 mg/kg/day (≤1000 mg) for 3 days. All personnel remained blinded except the local pharmacist. Infection was confirmed by immunoglobulin M antibodies or ANDV RNA in blood. The composite primary endpoint was death, partial pressure of arterial oxygen/fraction of inspired oxygen ratio ≤55, cardiac index ≤2.2, or ventricular tachycardia or fibrillation within 28 days. Safety endpoints included the number of serious adverse events (SAEs) and quantification of viral RNA in blood. Analysis was by intention to treat. RESULTS: Infection was confirmed in 60 of 66 (91%) enrollees. Fifteen of 30 placebo-treated patients and 11 of 30 methylprednisolone-treated patients progressed to the primary endpoint (P = .43). We observed no significant difference in mortality between treatment groups (P = .41). There was a trend toward more severe disease in placebo recipients at entry. More subjects in the placebo group experienced SAEs (P = .02). There were no SAEs clearly related to methylprednisolone administration, and methylprednisolone did not increase viral load. CONCLUSIONS: Although methylprednisolone appears to be safe, it did not provide significant clinical benefit to patients. Our results do not support the use of methylprednisolone for HCPS. CLINICAL TRIALS REGISTRATION: NCT00128180.

BACKGROUND: Longitudinal cohort data of patients with tuberculosis (TB) and coronavirus disease 2019 (COVID-19) are lacking. In our global study, we describe long-term outcomes of patients affected by TB and COVID-19. METHODS: We collected data from 174 centres in 31 countries on all patients affected by COVID-19 and TB between 1 March 2020 and 30 September 2022. Patients were followed-up until cure, death or end of cohort time. All patients had TB and COVID-19; for analysis purposes, deaths were attributed to TB, COVID-19 or both. Survival analysis was performed using Cox proportional risk-regression models, and the log-rank test was used to compare survival and mortality attributed to TB, COVID-19 or both. RESULTS: those dying because of either TB or COVID-19 alone (p<0.001). Significant adjusted risk factors for TB mortality were higher age (hazard ratio (HR) 1.05, 95% CI 1.03-1.07), HIV infection (HR 2.29, 95% CI 1.02-5.16) and invasive ventilation (HR 4.28, 95% CI 2.34-7.83). For COVID-19 mortality, the adjusted risks were higher age (HR 1.03, 95% CI 1.02-1.04), male sex (HR 2.21, 95% CI 1.24-3.91), oxygen requirement (HR 7.93, 95% CI 3.44-18.26) and invasive ventilation (HR 2.19, 95% CI 1.36-3.53). CONCLUSIONS: In our global cohort, death was the outcome in >10% of patients with TB and COVID-19. A range of demographic and clinical predictors are associated with adverse outcomes.

BACKGROUND: Even in metropolitan areas, on-call pediatric surgeons may not always be immediately available for surgical care of appendicitis, potentially leading to delays in care. In 2012, the in-house trauma group at a suburban Level 1 trauma center (none with formal pediatric fellowship training) assumed surgical care of 5-year- to 10-year-old children with appendicitis, who had previously been cared for by pediatric surgeons. We propose to compare the outcomes of the trauma and pediatric surgery groups. METHODS: Retrospective chart review of 5-year- to 10-year-olds undergoing emergency appendectomy at a suburban Level 1 trauma center between January 2007 and December 2016 was performed. Patients were classified as having surgery performed by the trauma surgery group or the pediatric surgery group. Patient characteristics, clinical course, and outcomes were compared. RESULTS: A total of 220 patients were identified for study, 138 in the trauma group and 82 in the pediatric surgery group. Patients cared for by the trauma group were more likely to be female (47% vs. 32%; p = 0.03), were less likely to be diagnosed without imaging (2% vs. 26%; p < 0.0001), had a shorter time from diagnosis to surgery (214 vs. 318 minutes; p = 0.01), were more likely to have laparoscopic surgery (70% vs. 55%; p = 0.04), had a shorter operative time (40 vs. 49 minutes; p < 0.0001), and had a shorter length of stay (32 vs. 41 hours; p < 0.0001), despite more of them needing to be transferred from outside hospitals (60% vs. 37%; p < 0.001). There were no significant differences in patient age, rate of perforated appendicitis, 30-day readmissions, surgical site infections, or unanticipated procedures. CONCLUSIONS: Trauma surgeon performance of emergency appendectomy in 5-year- to 10-year-old children decreased length of hospitalization with similar complication rates as compared with pediatric surgeons. LEVEL OF EVIDENCE: Therapeutic study, level IV.