Background There is a growing interest in Klebsiella variicola as a causative pathogen in humans, though its clinical features and the impact of co-infection or secondary infection with COVID-19 remain unknown. Case presentation A 71-year-old man presented with fever, altered mental status and generalized weakness and was admitted to ICU due to severe COVID-19 pneumonia. He was newly diagnosed with type II diabetes mellitus upon admission. On hospital day 3, his respiratory status deteriorated, requiring invasive mechanical ventilation. On hospital day 10, superimposed bacterial pneumonia was suspected and subsequently, broad-spectrum antibiotics were administered for the associated bloodstream infection. On hospital day 13, despite administration of active antibiotics and appropriate source control, he decompensated and died. The causative organism isolated from blood cultures was initially reported as K. pneumoniae, but it was identified as K. variicola by a genetic analysis. A representative isolate (FUJ01370) had a novel multilocus sequence typing allelic profile (gapA-infB-mdh-pgi-phoE-rpoB-tonB: 16-24-21-27-52-17-152), to which sequence type 5794 was assigned (GenBank assembly accession: GCA_019042755.1). Conclusions We report a fatal case of respiratory and bloodstream infection due to K. variicola complicating severe COVID-19. Co-infection or secondary infection of K. variicola in COVID-19 is likely under-recognized and can be fulminant as in this case.

Background Implementation of high-quality clinical trials especially early in the pandemic caused burden on clinical investigators given lack infrastructure, networks and systematic supports. To prepare for future pandemic, we investigated facilitator and obstacles that enable investigators to operate clinical trials for COIVD-19 in Japan. Methods We conducted individual semistructured qualitative interviews to assess the process of how clinical trials for COVID-19 were planned and implemented at the early stage of pandemic. Clinical investigators were primarily selected through purposive sampling to ensure that participants involved in the clinical trials were well covered. Additional participants were identified using snowball sampling. Interviews were analyzed using qualitative descriptive method. Results Through interviews, we identify factors that can impact on conduct clinical trials in infectious diseases field during health emergency in Japan (Figure). First, there are obstacles in rolling out clinical trials and this theme was further divided into two subthemes: obstacles in system(such as lack of regulatory frameworks to support trials, lack of clinical trial networks/platform, and understanding and attitude of the public to clinical trial); and obstacles in clinical level (such as limited resource for non-academic hospitals to implement clinical trials, and lack of trained experienced researchers and coordinators with regards to clinical trials). Secondary, a few factors that facilitate clinical trials exist. Not only governmental and organizational commitment but also presence of physicians and other healthcare professional interested in conducting trials are the key for facilitate clinical trials. Facilitators and obstacles to implement clinical trials for COVID-19 therapeutics Conclusion In this qualitative study, clinical investigators in Japan who conducted clinical trials recognized both obstacles and facilitators. System level obstacles likely led to the obstacles in clinical level. Our finding emphasizes importance for health care policies to respond to such insight from front line clinical investigators to encourage systemwide efforts to facilitate and develop transparent clinical trials during future pandemic. Disclosures All Authors: No reported disclosures.

Background Epidemiological interaction of drug resistant organisms between ICU and surrounding health facilities including LTACs have been of interest in the era of antimicrobial resistance (AMR) and aging society. In addition, conventional molecular epidemiology methods such as pulsed-field gel electrophoresis, and multilocus sequence typing are time-consuming and difficult to perform in a standard microbiology laboratory. Methods Patients admitted to a university-affiliated community hospital in Japan was recruited if their cultures collected clinically during admission grew the following target pathogens: Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin Resistant Enterococci (VRE), ESBL Gram negative rods (GNR), carbapenem-resistant Enterobacteriaceae (CRE), multi-drug resistant Pseudomonas (MDRP) and Clostridioides difficile (C. diff). Their clinical information including admission to ICU/step-down unit vs regular wards and disposition was analyzed with chi-square test for binary outcomes. For the isolates of MRSA, ESBL E. coli, and C. diff, further molecular epidemiology analysis was made, using PCR-based open-reading frame (ORF) Typing (POT method), a more resource-friendly and time-efficient technology originally developed in Japan. Results Among total 9639 hospital admissions in 2018-2019, the above-mentioned target pathogens grew from 233 patients (2.4%). There were 96 MRSA isolates (41.2%, out of 233), followed by 93 ESBL GNR (39.9%), 21 C. diff (9.0%), 13 CRE (5.6%), 10 MDRP (4.3%), and no VRE, respectively. Patients admitted to ICU/step-down unit were more likely to grow the target pathogens (117/1605 vs 116/7801, RR 4.90, 95% CI 3.81-6.30, p< 0.001), and to be discharged to LTACs than patients admitted to regular wards (70/113 vs 32/116, RR 2.17, 95% CI 1.56-3.02). Molecular epidemiology analysis with POT method identified 5, 3 and 3 common strains across 20, 11, and 7 patients with MRSA, ESBL E.coli, C. diff, respectively. Conclusion The study suggests the pathogens of higher priority were more prevalent in ICU/step-down unit and that the discharge from ICU/step-down unit to LTACs could impact on further transmission in the surrounding region. POT method can be utilized for more efficient molecular epidemiology analysis in the era of AMR. Disclosures All Authors: No reported disclosures.