Background: Nearly one-third of patients on hemodialysis receive intravenous (IV) antibiotics annually, but national data characterizing antibiotic use in this population are limited. Using NHSN surveillance data for outpatient dialysis facilities, we estimated temporal changes in the rate of IV antibiotic starts (IVAS) among hemodialysis patients as well as the proportion of IVAS that were not supported by a reported clinical indication. Methods: IVAS events were obtained from the NHSN Dialysis Event module between 2016 and 2020, excluding patients who were out of network, receiving peritoneal or home dialysis, or with unspecified vascular access. IVAS unsupported by documentation were defined as new IVAS without a collected or positive blood culture, pus, redness or swelling event, or an associated clinical symptom. Pooled mean rates of total and unsupported IVAS were estimated per 100 patient months yearly and stratified by vascular access type. Differences in IVAS rates by year were estimated with negative binomial regression. Results: Between 2016 and 2020, 7,278 facilities reported 648,410 IVAS events; 161,317 (25%) were unsupported by documentation (Table 1). In 2016, 3,340 (54%) facilities with ≥1 IVAS event reported an IVAS unsupported by documentation, which increased to 4,994 (73%) in 2020. Total IVAS rates decreased by an average of 8.2% annually (95% CI, 7.1%–9.3%; P < .001). The average annual percentage decrease did not differ significantly by vascular access site. The total IVAS rate was lowest in 2020 (2.17 per 100 patient months; 95% CI, 2.18–2.17). IVAS rates in 2020 were greatest for patients with catheter access (4.79 per 100 patient months; 95% CI, 4.75–4.83), followed by graft (1.71 per 100 patient months; 95% CI, 1.68–1.73), and lowest for patients with fistulas (1.30 per 100 patient months; 95% CI, 1.29–1.31). The overall pooled mean rate of unsupported IVAS was 0.64 per 100 patient months (95% CI, 0.63–0.64), which did not significantly change by year (Fig. 1). Conclusions: Total IVAS rates among outpatient hemodialysis patients have decreased since 2016, and rates among catheter patients remain highest compared to patients with fistulas or grafts. However, unsupported IVAS rates did not change, and the proportion of facilities reporting an unsupported IVAS increased annually. Targeted efforts to engage facilities with unsupported IVAS may help improve accurate reporting and prescribing practices.

Funding: None

Disclosures: None

Background: The emergence and spread of drug-resistant pathogens continues to significantly impact patient safety and healthcare systems. Although antimicrobial susceptibility test (AST) results of clinical specimens are used by individual facilities for antimicrobial resistance surveillance, accurate tracking and benchmark comparison of a facility’s antimicrobial resistance using national data requires risk-adjusted methods to be more meaningful. The CDC NHSN Antimicrobial Resistance (AR) Option collects patient-level, deduplicated, isolate information, including AST results, for >20 organisms from cerebrospinal fluid, lower respiratory tract (LRT), blood, and urinary specimens. To provide risk-adjusted national benchmarks, we developed prediction models for incidence of hospital-onset isolates with antimicrobial resistance. Methods: We analyzed AST results of isolates reported through the NHSN AR Option for January through December 2019. Isolates from facilities that had >10% missing AST results for the organism-drug combinations or from hospitals that used outdated breakpoints were excluded. We assessed associations between facility-level factors and incidence rates of hospital-onset (specimen collected 3 days or more after hospital admission) isolates of specific drug-resistant phenotypes from blood, LRT, and urinary specimens. Factors included number of beds, length of stay, and prevalence of community onset isolates of the same phenotype. Drug-resistant phenotypes assessed included methicillin-resistant Staphylococcus aureus (MRSA), multidrug-resistant (MDR) Pseudomonas aeruginosa, carbapenem-resistant Enterobacterales (CRE), fluoroquinolone-resistant Pseudomonas aeruginosa, fluoroquinolone-resistant Enterobacterales, and extended-spectrum cephalosporin-resistant Enterobacterales. Isolates of different phenotypes and from different specimen sources were modeled separately. Negative binomial regression was used to evaluate the factors associated with antimicrobial resistance incidence. Variable entry into the models is based on significance level P Among the models, 1 for each drug-resistant phenotype-specimen type combination, the number of isolates with AST results ranged from 718 (Pseudomonas aeruginosa–fluoroquinolones, blood) to 16,412 (Enterobacterales–fluoroquinolones, urine). The pooled incidence rate was highest for fluoroquinolone-resistant Enterobacterales in urinary specimens (0.2179 isolates per 1,000 patient days) among all phenotype-specimen combinations evaluated (Table 1). The incidence of drug-resistant isolates was consistently associated with community-onset prevalence across models evaluated. Other associated factors varied across phenotype-specimen combinations (Table 2). Conclusions: We developed statistical models to predict facility-level incidence rates of hospital-onset antimicrobial resistant isolates based on community-onset drug-resistant prevalence and facility characteristics. These models will enable facilities to compare antimicrobial resistance rates to the national benchmarks and therefore to inform their antimicrobial stewardship and infection prevention efforts.

Funding: None

Disclosures: None

Monoclonal antibody therapeutics to treat coronavirus disease (COVID-19) have been authorized by the US Food and Drug Administration under Emergency Use Authorization (EUA). Many barriers exist when deploying a novel therapeutic during an ongoing pandemic, and it is critical to assess the needs of incorporating monoclonal antibody infusions into pandemic response activities. We examined the monoclonal antibody infusion site process during the COVID-19 pandemic and conducted a descriptive analysis using data from 3 sites at medical centers in the United States supported by the National Disaster Medical System. Monoclonal antibody implementation success factors included engagement with local medical providers, therapy batch preparation, placing the infusion center in proximity to emergency services, and creating procedures resilient to EUA changes. Infusion process challenges included confirming patient severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positivity, strained staff, scheduling, and pharmacy coordination. Infusion sites are effective when integrated into pre-existing pandemic response ecosystems and can be implemented with limited staff and physical resources.

Background: Antibiotics targeted against Clostridioides difficile bacteria are necessary, but insufficient, to achieve a durable clinical response because they have no effect on C. difficile spores that germinate within a disrupted microbiome. ECOSPOR-III evaluated SER-109, an investigational, biologically derived microbiome therapeutic of purified Firmicute spores for treatment of rCDI. Herein, we present the interim analysis in the ITT population at 8 and 12 weeks. Methods: Adults ≥18 years with rCDI (≥3 episodes in 12 months) were screened at 75 US and CAN sites. CDI was defined as ≥3 unformed stools per day for <48 hours with a positive C. difficile assay. After completion of 10–21 days of vancomycin or fidaxomicin, adults with symptom resolution were randomized 1:1 to SER-109 (4 capsules × 3 days) or matching placebo and stratified by age (≥ or <65 years) and antibiotic received. Primary objectives were safety and efficacy at 8 weeks. Primary efficacy endpoint was rCDI (recurrent toxin+ diarrhea requiring treatment); secondary endpoints included efficacy at 12 weeks after dosing. Results: Overall, 287 participants were screened and 182 were randomized (59.9% female; mean age, 65.5 years). The most common reason for screen failure was a negative C. difficile toxin assay. A significantly lower proportion of SER-109 participants had rCDI after dosing compared to placebo at week 8 (11.1% vs 41.3%, respectively; relative risk [RR], 0.27; 95% confidence interval [CI], 0.15–0.51; p-value <0.001). Efficacy rates were significantly higher with SER-109 vs placebo in both stratified age groups (Figure 1). SER-109 was well-tolerated with a safety profile similar to placebo. The most common treatment-emergent adverse events (TEAEs) were gastrointestinal and were mainly mild to moderate. No serious TEAEs, infections, deaths, or drug discontinuations were deemed related to study drug. Conclusions: SER-109, an oral live microbiome therapeutic, achieved high rates of sustained clinical response with a favorable safety profile. By enriching for Firmicute spores, SER-109 achieves high efficacy while mitigating risk of transmitting infectious agents, beyond donor screening alone. SER-109 represents a major paradigm shift in the clinical management of patients with recurrent CDI. Clinicaltrials.gov Identifier NCT03183128. These data were previously presented as a late breaker at American College of Gastroenterology 2020.

Funding: Seres Therapeutics

Disclosures: None

Figure 1.

During March 27–July 14, 2020, the Centers for Disease Control and Prevention’s National Healthcare Safety Network extended its surveillance to hospital capacities responding to COVID-19 pandemic. The data showed wide variations across hospitals in case burden, bed occupancies, ventilator usage, and healthcare personnel and supply status. These data were used to inform emergency responses.