Effect of Bamlanivimab vs Placebo on Incidence of COVID-19 Among Residents and Staff of Skilled Nursing and Assisted Living Facilities: A Randomized Clinical Trial.

Importance: Preventive interventions are needed to protect residents and staff of skilled nursing and assisted living facilities from COVID-19 during outbreaks in their facilities. Bamlanivimab, a neutralizing monoclonal antibody against SARS-CoV-2, may confer rapid protection from SARS-CoV-2 infection and COVID-19. Objective: To determine the effect of bamlanivimab on the incidence of COVID-19 among residents and staff of skilled nursing and assisted living facilities. Design, Setting, and Participants: Randomized, double-blind, single-dose, phase 3 trial that enrolled residents and staff of 74 skilled nursing and assisted living facilities in the United States with at least 1 confirmed SARS-CoV-2 index case. A total of 1175 participants enrolled in the study from August 2 to November 20, 2020. Database lock was triggered on January 13, 2021, when all participants reached study day 57. Interventions: Participants were randomized to receive a single intravenous infusion of bamlanivimab, 4200 mg (n = 588), or placebo (n = 587). Main Outcomes and Measures: The primary outcome was incidence of COVID-19, defined as the detection of SARS-CoV-2 by reverse transcriptase-polymerase chain reaction and mild or worse disease severity within 21 days of detection, within 8 weeks of randomization. Key secondary outcomes included incidence of moderate or worse COVID-19 severity and incidence of SARS-CoV-2 infection. Results: The prevention population comprised a total of 966 participants (666 staff and 300 residents) who were negative at baseline for SARS-CoV-2 infection and serology (mean age, 53.0 [range, 18-104] years; 722 [74.7%] women). Bamlanivimab significantly reduced the incidence of COVID-19 in the prevention population compared with placebo (8.5% vs 15.2%; odds ratio, 0.43 [95% CI, 0.28-0.68]; P < .001; absolute risk difference, -6.6 [95% CI, -10.7 to -2.6] percentage points). Five deaths attributed to COVID-19 were reported by day 57; all occurred in the placebo group. Among 1175 participants who received study product (safety population), the rate of participants with adverse events was 20.1% in the bamlanivimab group and 18.9% in the placebo group. The most common adverse events were urinary tract infection (reported by 12 participants [2%] who received bamlanivimab and 14 [2.4%] who received placebo) and hypertension (reported by 7 participants [1.2%] who received bamlanivimab and 10 [1.7%] who received placebo). Conclusions and Relevance: Among residents and staff in skilled nursing and assisted living facilities, treatment during August-November 2020 with bamlanivimab monotherapy reduced the incidence of COVID-19 infection. Further research is needed to assess preventive efficacy with current patterns of viral strains with combination monoclonal antibody therapy. Trial Registration: ClinicalTrials.gov Identifier: NCT04497987.

Successful control of an outbreak of Klebsiella pneumoniae carbapenemase-producing K. pneumoniae at a long-term acute care hospital.

OBJECTIVE: To determine the effect of a bundle of infection control interventions on the horizontal transmission of Klebsiella pneumoniae carbapenemase (KPC)-producing K. pneumoniae during an outbreak. DESIGN: Quasi-experimental study. Setting. Long-term acute care hospital. Intervention. On July 23, 2008, a bundled intervention was implemented: daily 2% chlorhexidine gluconate baths for patients, enhanced environmental cleaning, surveillance cultures at admission, serial point prevalence surveillance (PPS), isolation precautions, and training of personnel. Baseline PPS was performed before the intervention was implemented. Any gram-negative rod isolate suspected of KPC production underwent a modified Hodge test and, if results were positive, confirmatory polymerase chain reaction testing. Clinical cases were defined to occur for patients whose samples yielded KPC-positive gram-negative rods in clinical cultures. RESULTS: Baseline PPS performed on June 17, 2008, showed a prevalence of colonization with KPC-producing isolates of 21% (8 of 39 patients screened). After implementation of the intervention, monthly PPS was performed 5 times, which showed prevalences of colonization with KPC-producing isolates of 12%, 5%, 3%, 0%, and 0% (P < .001). From January 1, 2008, until the intervention, 8 KPC-positive clinical cases--suspected to be due to horizontal transmission--were detected. From implementation of the intervention through December 31, 2008, only 2 KPC-positive clinical cases, both in August 2008, were detected. From January 1 through December 31, 2008, 8 patients were detected as carriers of KPC-producing isolates at admission to the institution, 4 patients before and 4 patients after the intervention. CONCLUSION: A bundled intervention was successful in preventing horizontal spread of KPC-producing gram-negative rods in a long-term acute care hospital, despite ongoing admission of patients colonized with KPC producers.

Four years of surveillance cultures at a long-term acute care hospital.

OBJECTIVE: To characterize the degree of colonization with multidrug-resistant organisms (MDROs) among patients admitted to a long-term acute care hospital. DESIGN: Ecologic study. SETTING: A 70-bed long-term acute care hospital (a hospital within a hospital) in the greater Chicago area. METHODS: As part of an infection control initiative, specimens were collected from all consecutively admitted patients for culture of MDROs within 72 hours of admission. Cultures from July 28, 2005, through November 1, 2008, were analyzed on the basis of the bodily site from which the isolate was recovered and the organisms identified. If MDROs were yielded by culture of specimens that were obtained from 24 hours to 30 days after collection of the patient's original set of specimens, these MDROs were removed from the analysis. In addition, repeat rectal swab samples were collected for culture at 2 weeks after admission for all consecutive patients admitted from January 1 through March 31, 2007. RESULTS: A total of 1,739 patients with a total of 5,198 specimens met entry criteria. Of the corresponding 5,198 surveillance cultures, 1,580 (30%) were positive for MDROs. Of the 1,739 patients, 947 (54%) had a culture-positive specimen recovered from any site. Vancomycin-resistant Enterococcus was the organism most commonly isolated in cultures of rectal swab samples (in 38% of such cultures) and wounds (in 18% of such cultures). The rate of rectal carriage of vancomycin-resistant Enterococcus increased from 29% in 2005 to 44% in 2008.

Prevention of bloodstream infections by use of daily chlorhexidine baths for patients at a long-term acute care hospital.

OBJECTIVE: To evaluate the effect of bathing patients with 2% chlorhexidine on the rates of central vascular catheter (CVC)-associated bloodstream infection (BSI) at a long-term acute care hospital (LTACH). DESIGN: Quasi-experimental study. SETTING: A 70-bed LTACH in the greater Chicago area. PATIENTS: All consecutive patients admitted to the LTACH during the period from February 2006 to February 2008. METHODS: For patients at the LTACH, daily 2% chlorhexidine baths were instituted during the period from September 2006 until May 2007 (ie, the intervention period). A preintervention period (in which patients were given daily soap-and-water baths) and a postintervention period (in which patients were given daily nonmedicated baths and weekly 2% chlorhexidine baths) were also observed. The rates of CVC-associated BSI and ventilator-associated pneumonia were analyzed for the intervention period and for the pre- and postintervention periods. RESULTS: The rates of CVC-associated BSI were 9.5, 3.8, and 6.4 cases per 1,000 CVC-days during the preintervention, intervention, and postintervention periods, respectively. By the end of the intervention period, there was a net reduction of 99% in the CVC-associated BSI rate. No changes were seen in the rates of ventilator-associated pneumonia during the preintervention and intervention periods. CONCLUSION: Daily chlorhexidine baths appeared to be an effective intervention to reduce rates of CVC-associated BSI in an LTACH.