Patients’ Experiences With <i>Staphylococcus aureus</i> and Gram-Negative Bacterial Bloodstream Infections: Results From Cognitive Interviews to Inform Assessment of Health-Related Quality of Life

King, Heather A.; Doernberg, Sarah B; Grover, Kiran; Miller, John N.; Oakes, Megan; Wang, Tsai-Wei; McFatrich, Molly; Ruffin, Felicia; Staman, Karen; Lane, Hannah; Rader, Abigail; Sund, Zoë; Bosworth, Hayden B.; Reeve, Bryce B.; Fowler, Vance G.; Holland, David

doi:10.1093/ofid/ofab622

Cited by 3 publications

(1 citation statement)

References 20 publications

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“…Infectious diseases lags other fields in developing and validating patient-reported outcome measures, particularly for bacterial syndromes commonly caused by antibiotic-resistant organisms. 54 In recent years, progress [55][56][57] toward measures for pneumonia, skin and skin structure infection, and bloodstream infection have been encouraging. More work will be required to validate these measures and incorporate them prospectively into clinical trials.…”

Section: How Can Door Better Incorporate the Patient Voice?mentioning

confidence: 99%

Desirability of outcome ranking and quality life measurement for antimicrobial research in organ transplantation

Doernberg

2022

Transplant Infectious Dis

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Background: Current clinical trials of new antibiotics facilitate bringing new drugs to market but often fail to provide useful information for clinical decision making. Methods: Literature review of desirability of outcome ranking (DOOR) in antibiotic clinical trials and description how DOOR can fit into design, administration, and assessment of clinical trials. Results: DOOR is an approach that addresses many of the shortcomings of current trials by incorporating efficacy and safety into a single outcome to analyze the patient experience in its entirety. Application of partial credit, tiebreaker strategies including response adjusted for duration of antibiotic risk (RADAR), and DOOR for Management of Antimicrobial Therapy (DOOR MAT) provides additional nuance and granularity. To address pitfalls of DOOR, investigators must develop the DOOR a priori, ideally with input from and incorporation of patient voices, and should perform component analysis to ensure that imbalances in key components are detected. Conclusion: Inclusion of DOOR in clinical trials will enrich our understanding of how new antibiotics might benefit patients who have had transplantation. Additional work to develop best practices for DOOR selection, analysis, and interpretation must continue, and incorporation of the patient perspective is essential. K E Y W O R D S antibiotic-resistant bacteria, clinical trial design, desirability of outcome ranking, health-related quality of life THE CURRENT STATE OF CLINICAL TRIALS FOR NEW ANTIBIOTICSAntibiotics have saved millions of lives in the modern medical era and helped pave the way for modern surgical development, including solid organ transplantation. 1,2 However, in the setting of immunosuppression, anatomic issues that arise after surgery, donor-derived

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Section: How Can Door Better Incorporate the Patient Voice?mentioning

confidence: 99%

Desirability of outcome ranking and quality life measurement for antimicrobial research in organ transplantation

Doernberg

2022

Transplant Infectious Dis

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Priorities and Progress in Gram-positive Bacterial Infection Research by the Antibacterial Resistance Leadership Group: A Narrative Review

Doernberg,

Arias,

Altman

et al. 2023

Clinical Infectious Diseases

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The Antibacterial Resistance Leadership Group (ARLG) has prioritized infections caused by gram-positive bacteria as one of its core areas of emphasis. The ARLG Gram-positive Committee has focused on studies responding to 3 main identified research priorities: (1) investigation of strategies or therapies for infections predominantly caused by gram-positive bacteria, (2) evaluation of the efficacy of novel agents for infections caused by methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci, and (3) optimization of dosing and duration of antimicrobial agents for gram-positive infections. Herein, we summarize ARLG accomplishments in gram-positive bacterial infection research, including studies aiming to (1) inform optimal vancomycin dosing, (2) determine the role of dalbavancin in MRSA bloodstream infection, (3) characterize enterococcal bloodstream infections, (4) demonstrate the benefits of short-course therapy for pediatric community-acquired pneumonia, (5) develop quality of life measures for use in clinical trials, and (6) advance understanding of the microbiome. Future studies will incorporate innovative methodologies with a focus on interventional clinical trials that have the potential to change clinical practice for difficult-to-treat infections, such as MRSA bloodstream infections.

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Dalbavancin as an option for treatment of S. aureus bacteremia (DOTS): study protocol for a phase 2b, multicenter, randomized, open-label clinical trial

Turner

Zaharoff

King

et al. 2022

Trials

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Background Staphylococcus aureus bacteremia is a life-threatening infection and leading cause of infective endocarditis, with mortality rates of 15–50%. Treatment typically requires prolonged administration of parenteral therapy, itself associated with high costs and potential catheter-associated complications. Dalbavancin is a lipoglycopeptide with potent activity against Staphylococcus and a long half-life, making it an appealing potential therapy for S. aureus bacteremia without the need for durable central venous access. Methods DOTS is a phase 2b, multicenter, randomized, assessor-blinded, superiority, active-controlled, parallel-group trial. The trial will enroll 200 adults diagnosed with complicated S. aureus bacteremia, including definite or possible right-sided infective endocarditis, who have been treated with effective antibiotic therapy for at least 72 h (maximum 10 days) and with subsequent clearance of bacteremia prior to randomization to study treatment. Subjects will be randomized 1:1 to complete their antibiotic treatment course with either two doses of dalbavancin on days 1 and 8, or with a total of 4–8 weeks of standard intravenous antibiotic therapy. The primary objective is to compare the Desirability of Outcome Ranking (DOOR) at day 70 for patients randomized to dalbavancin versus standard of care. Key secondary endpoints include quality of life outcomes and pharmacokinetic analyses of dalbavancin. Discussion The DOTS trial will establish whether dalbavancin is superior to standard parenteral antibiotic therapy for the completion of treatment of complicated S. aureus bacteremia. Trial registration US National Institutes of Health ClinicalTrials.govNCT04775953. Registered on 1 March 2021

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Patients’ Experiences With Staphylococcus aureus and Gram-Negative Bacterial Bloodstream Infections: Results From Cognitive Interviews to Inform Assessment of Health-Related Quality of Life

Cited by 3 publications

References 20 publications

Desirability of outcome ranking and quality life measurement for antimicrobial research in organ transplantation

Desirability of outcome ranking and quality life measurement for antimicrobial research in organ transplantation

Priorities and Progress in Gram-positive Bacterial Infection Research by the Antibacterial Resistance Leadership Group: A Narrative Review

Dalbavancin as an option for treatment of S. aureus bacteremia (DOTS): study protocol for a phase 2b, multicenter, randomized, open-label clinical trial

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