Faculty Bibliography
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17
Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials
Substantial COVID-19 research investment has been allocated to randomized clinical trials (RCTs) on hydroxychloroquine/chloroquine, which currently face recruitment challenges or early discontinuation. We aim to estimate the effects of hydroxychloroquine and chloroquine on survival in COVID-19 from all currently available RCT evidence, published and unpublished. We present a rapid meta-analysis of ongoing, completed, or discontinued RCTs on hydroxychloroquine or chloroquine treatment for any COVID-19 patients (protocol: https://osf.io/QESV4/ ). We systematically identified unpublished RCTs (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, Cochrane COVID-registry up to June 11, 2020), and published RCTs (PubMed, medRxiv and bioRxiv up to October 16, 2020). All-cause mortality has been extracted (publications/preprints) or requested from investigators and combined in random-effects meta-analyses, calculating odds ratios (ORs) with 95% confidence intervals (CIs), separately for hydroxychloroquine and chloroquine. Prespecified subgroup analyses include patient setting, diagnostic confirmation, control type, and publication status. Sixty-three trials were potentially eligible. We included 14 unpublished trials (1308 patients) and 14 publications/preprints (9011 patients). Results for hydroxychloroquine are dominated by RECOVERY and WHO SOLIDARITY, two highly pragmatic trials, which employed relatively high doses and included 4716 and 1853 patients, respectively (67% of the total sample size). The combined OR on all-cause mortality for hydroxychloroquine is 1.11 (95% CI: 1.02, 1.20; I² = 0%; 26 trials; 10,012 patients) and for chloroquine 1.77 (95%CI: 0.15, 21.13, I² = 0%; 4 trials; 307 patients). We identified no subgroup effects. We found that treatment with hydroxychloroquine is associated with increased mortality in COVID-19 patients, and there is no benefit of chloroquine. Findings have unclear generalizability to outpatients, children, pregnant women, and people with comorbidities.
PMID: 33859192
ISSN: 2041-1723
CID: 4846322
Treating COVID-19 With Hydroxychloroquine (TEACH): A Multicenter, Double-Blind Randomized Controlled Trial in Hospitalized Patients
Background/UNASSIGNED:Effective therapies to combat coronavirus 2019 (COVID-19) are urgently needed. Hydroxychloroquine (HCQ) has in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but the clinical benefit of HCQ in treating COVID-19 is unclear. Randomized controlled trials are needed to determine the safety and efficacy of HCQ for the treatment of hospitalized patients with COVID-19. Methods/UNASSIGNED:We conducted a multicenter, double-blind randomized clinical trial of HCQ among patients hospitalized with laboratory-confirmed COVID-19. Subjects were randomized in a 1:1 ratio to HCQ or placebo for 5 days and followed for 30 days. The primary efficacy outcome was a severe disease progression composite end point (death, intensive care unit admission, mechanical ventilation, extracorporeal membrane oxygenation, and/or vasopressor use) at day 14. Results/UNASSIGNED: = .350). There were no significant differences in COVID-19 clinical scores, number of oxygen-free days, SARS-CoV-2 clearance, or adverse events between HCQ and placebo. HCQ was associated with a slight increase in mean corrected QT interval, an increased D-dimer, and a trend toward an increased length of stay. Conclusions/UNASSIGNED:In hospitalized patients with COVID-19, our data suggest that HCQ does not prevent severe outcomes or improve clinical scores. However, our conclusions are limited by a relatively small sample size, and larger randomized controlled trials or pooled analyses are needed.
PMCID:7543602
PMID: 33134417
ISSN: 2328-8957
CID: 4655862
Features of the Energy Spectrum of Cosmic Rays above 2.5×10^{18} eV Using the Pierre Auger Observatory
We report a measurement of the energy spectrum of cosmic rays above 2.5×10^{18} eV based on 215 030 events. New results are presented: at about 1.3×10^{19} eV, the spectral index changes from 2.51±0.03(stat)±0.05(syst) to 3.05±0.05(stat)±0.10(syst), evolving to 5.1±0.3(stat)±0.1(syst) beyond 5×10^{19} eV, while no significant dependence of spectral features on the declination is seen in the accessible range. These features of the spectrum can be reproduced in models with energy-dependent mass composition. The energy density in cosmic rays above 5×10^{18} eV is [5.66±0.03(stat)±1.40(syst)]×10^{53} erg Mpc^{-3}.
PMID: 33016715
ISSN: 1079-7114
CID: 5910932
Clostridioides difficile Enteritis in Patients Following Total Colectomy-a Rare but Genuine Clinical Entity
Objective/UNASSIGNED:enteritis prevalence, severity, and potential risk factors are unknown. Methods/UNASSIGNED:stool testing after colectomy. We compared CDE cases to controls using multivariable analysis to identify potential CDE risk factors. Results/UNASSIGNED:enteritis presented with severe disease half of the time, with 81.8% requiring hospitalization. Conclusions/UNASSIGNED:enteritis often presents as severe disease and frequently requires hospitalization.
PMCID:6822686
PMID: 31687419
ISSN: 2328-8957
CID: 4494762
Introduction of Procalcitonin Testing and Antibiotic Utilization for Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Background/UNASSIGNED:The majority of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are triggered by nonbacterial causes, yet most patients receive antibiotics. Treatment guided by procalcitonin (PCT), a sensitive biomarker of bacterial infection, safely decreases antibiotic use in many controlled trials. We evaluated PCT implementation for inpatients with AECOPD at a large academic hospital. Methods/UNASSIGNED:All patients admitted for AECOPD during the first 6 months of PCT-guided therapy were eligible for inclusion in this retrospective cohort study. Patients with PCT performed were compared with those without PCT. The primary outcome was antibiotic days of therapy (DOT). Secondary outcomes included 30-day readmission and mortality. Results/UNASSIGNED: ⩽ .001) decrease in intravenous (IV) antibiotic DOT. Guideline-recommended follow-up testing was rare (12%). Procalcitonin measurement had no effect on 30-day readmission or mortality. Conclusions/UNASSIGNED:In this real-world analysis of inpatients with AECOPD, PCT-guided therapy was poorly adopted by providers and was not associated with a decrease in total antibiotic DOT. However, a low PCT level was associated with a 25.5% decrease in IV antibiotic DOT, suggesting increased comfort stepping down from IV to PO therapy.
PMCID:6566468
PMID: 31223234
ISSN: 1178-6337
CID: 4494752
Is Clostridium difficile infection a risk factor for subsequent bloodstream infection?
BACKGROUND:Clostridium difficile infection (CDI) is a common nosocomial diarrheal illness increasingly associated with mortality in United States. The underlying factors and mechanisms behind the recent increases in morbidity from CDI have not been fully elucidated. Murine models suggest a mucosal barrier breakdown leads to bacterial translocation and subsequent bloodstream infection (BSI). This study tests the hypothesis that CDI is associated with subsequent BSI in humans. METHODS:We conducted a retrospective cohort study on 1132 inpatients hospitalized >72 h with available stool test results for toxigenic C. difficile. The primary outcome was BSI following CDI. Secondary outcomes included 30-day mortality, colectomy, readmission, and ICU admission. Unadjusted and adjusted logistic regression models were developed. RESULTS:CDI occurred in 570 of 1132 patients (50.4%). BSI occurred in 86 (7.6%) patients. Enterococcus (14%) and Klebsiella (14%) species were the most common organisms. Patients with BSI had higher comorbidity scores and were more likely to be male, on immunosuppression, critically ill, and have a central venous catheter in place. Of the patients with BSI, 36 (42%) had CDI. CDI was not associated with subsequent BSI (OR 0.69; 95% CI 0.44-1.08; P = 0.103) in unadjusted analysis. In multivariable modeling, CDI appeared protective against subsequent BSI (OR 0.57; 95% CI 0.34-0.96; P = 0.036). Interaction modeling suggests a complicated relationship among CDI, BSI, antibiotic exposure, and central venous catheter use. CONCLUSIONS:In this cohort of inpatients that underwent testing for CDI, CDI was not a risk factor for developing subsequent BSI.
PMCID:5711547
PMID: 28669864
ISSN: 1095-8274
CID: 4494742
Outcomes of patients undergoing percutaneous biliary drainage to reduce bilirubin for administration of chemotherapy
PURPOSE/OBJECTIVE:To describe outcomes in patients undergoing percutaneous biliary drainage to reduce total serum bilirubin level for administration of chemotherapy. MATERIALS AND METHODS/METHODS:A total of 647 consecutive patients underwent percutaneous biliary drainage between September 2001 and December 2008. In 168, the indication for biliary drainage was to decrease total serum bilirubin level to permit administration of chemotherapy. Of these, 20 were excluded because they had hepatic arterial infusion pumps, leaving 148 patients as the study group. The primary diagnoses for these patients were gallbladder cancer (n = 23), cholangiocarcinoma (n = 21), pancreatic cancer (n = 36), and other metastatic cancers (n = 68). Medical records and imaging studies were reviewed for demographic data, procedural information, pre- and postdrainage total serum bilirubin level levels, 30-day complications, and subsequent biliary procedures. RESULTS:The probability of attaining a total serum bilirubin level of 1 mg/dL or lower by 100 days was 31% (95% CI, 23%-39%). Predrainage total serum bilirubin level of 9 mg/dL or lower (hazard ratio [HR], 3.27; 95% CI, 1.86-5.75; P < .001), 100% liver drainage (HR 2.73, 95% CI, 1.56-4.78; P <.001), and lower predrainage International Normalized Ratio (INR; HR, 0.80; 95% CI, 0.70-0.92; P = .002) were associated with an increased likelihood of attaining a total serum bilirubin level of 1 mg/dL or lower. The most common indication for follow-up was pericatheter leakage, which occurred in nearly one third of cases. During follow-up, patients required three visits per 100 catheter-days, or approximately one per month. Median overall survival in this population was approximately 3.5 months. CONCLUSIONS:Only 31% of patients attained a normal serum bilirubin level by 100 days, and median overall survival was 107 days. Careful patient selection is warranted before biliary drainage for this indication. Maximal biliary drainage, a preprocedure total serum bilirubin of less than 9 mg/dL, and a lower INR were factors associated with serum bilirubin normalization in this cohort.
PMID: 22115568
ISSN: 1535-7732
CID: 4494772
