Evidence map›Paper›PMID 37740559›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024

Moving Beyond Mortality: Development and Application of a Desirability of Outcome Ranking (DOOR) Endpoint for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia.

Jessica Howard-Anderson, Toshimitsu Hamasaki, Weixiao Dai, Deborah Collyar, Daniel Rubin, Sumathi Nambiar, Tori Kinamon, Heidi Leister-Tebbe, Carol Hill, Holly Geres and 7 more

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07585604 (A Randomized Multicenter Clinical Trial Comparing BIOFIRE® FILMARRAY® Pneumonia), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.4field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07585604 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Randomized Multicenter Clinical Trial Comparing BIOFIRE® FILMARRAY® Pneumonia (PN) Panels Versus Routine Diagnostic Methods in Desirability of Outcome Ranking for the Management of Antimicrobial Therapy (DOOR MAT) in Hospitalized Patients With Lower Respiratory Tract Infections.

TypeinterventionalSponsorHospital de Clinicas de Porto AlegreRan2026 to 2027Enrolled150ConditionsPneumonia - BacterialArmsMultiplex PCR-based pneumonia panel (BIOFIRE® FILMARRAY® Pneumonia Panel)
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Beyond Bloodstream Infection: The Potential for Hierarchical Composite Endpoints in Vascular Access Research.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  5. Article
  6. Article
  7. Making Sense of Hierarchical Composite End Points in Randomized Clinical Trials-A Primer for Infectious Diseases Clinicians and Researchers.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Review
  8. Article
  9. Article
  10. Interagency Collaboration for Patient-Centered Antibacterial Drug Development.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 10 institutions in 1 country.

Jessica Howard-AndersonDivision of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.ORCID 0000-0001-9924-0458
Toshimitsu HamasakiBiostatistics Center and Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Washington, District of Columbia, USA.
Weixiao DaiBiostatistics Center and Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Washington, District of Columbia, USA.
Deborah CollyarPatient Advocates in Research, Danville, California, USA.
Daniel RubinCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Sumathi NambiarJohnson and Johnson, Raritan, New Jersey, USA.
Tori KinamonDepartment of Medicine, Duke University Medical Center, Durham, North Carolina, USA.
Heidi Leister-TebbePfizer Inc, Collegeville, Pennsylvania, USA.
Carol HillDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Holly GeresDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Thomas L HollandDepartment of Medicine, Duke University Medical Center, Durham, North Carolina, USA.
Sarah B DoernbergDivision of Infectious Diseases, Department of Medicine, University of California, SanFrancisco, USA.
Henry F ChambersDivision of Infectious Diseases, Department of Medicine, University of California, SanFrancisco, USA.
Vance G FowlerDepartment of Medicine, Duke University Medical Center, Durham, North Carolina, USA.
Scott R EvansBiostatistics Center and Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Washington, District of Columbia, USA.
Helen W BoucherDivision of Geographic Medicine and Infectious Diseases, Department of Medicine, Tufts University School of Medicine.
Antibacterial Resistance Leadership Group
Duke University · USMilken Institute · USTufts University · USUniversity of California, San Francisco · USEmory University · USJohnson & Johnson (United States) · USOrthopaedic Research of Virginia · USUnited States Food and Drug Administration · USDuke Medical Center · USPfizer (United States) · US

Funding

Antibacterial Resistance Leadership Group (ARLG)UM1AI104681 · NIAID · DUKE UNIVERSITY · PI Vance G. Fowler, Henry F HENRY CHAMBERS · 2013 to 2026
$180.8M
HLA Fine Mapping to Elucidate S. aureus SusceptibilityR01AI165671 · NIAID · DUKE UNIVERSITY · PI FOWLER, VANCE G., SCOTT, WILLIAM K · 2021 to 2025
$3.8M
NIAID NIH HHS R01 AI165671NIAID NIH HHS UM1 AI104681NIH HHS UM1AI104681
6 · The paper itself

Abstract

backgroundHospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) are frequently caused by multidrug-resistant organisms. Patient-centered endpoints in clinical trials are needed to develop new antibiotics for HABP/VABP. Desirability of outcome ranking (DOOR) is a paradigm for the design, analysis, and interpretation of clinical trials based on a patient-centered, benefit-risk evaluation.

methodsA multidisciplinary committee created an infectious diseases DOOR endpoint customized for HABP/VABP, incorporating infectious complications, serious adverse events, and mortality. We applied this to 2 previously completed, large randomized controlled trials for HABP/VABP. ZEPHyR compared vancomycin to linezolid and VITAL compared linezolid to tedizolid. For each trial, we evaluated the DOOR distribution and probability, including DOOR component and partial credit analyses. We also applied DOOR in subgroup analyses.

resultsIn both trials, the HABP/VABP DOOR demonstrated similar overall clinical outcomes between treatment groups. In ZEPHyR, the probability that a participant treated with linezolid would have a more desirable outcome than a participant treated with vancomycin was 50.2% (95% confidence interval [CI], 45.1%--55.3%). In VITAL, the probability that a participant treated with tedizolid would have a more desirable outcome than a participant treated with linezolid was 48.7% (95% CI, 44.8%-52.6%). The DOOR component analysis revealed that participants treated with tedizolid had a less desirable outcome than those treated with linezolid when considering clinical response alone. However, participants with decreased renal function had improved overall outcomes with tedizolid.

conclusionsThe HABP/VABP DOOR provided more granular information about clinical outcomes than is typically presented in clinical trials. HABP/VABP trials would benefit from prospectively using DOOR.

Indexed as

Healthcare-Associated PneumoniaPneumonia, BacterialPneumonia, Ventilator-AssociatedAnti-Bacterial AgentsBacteriaHospitalsHumansLinezolidVancomycinVentilators, MechanicalAnti-Bacterial AgentsLinezolidVancomycinclinical trialsdesirability of outcome rankingdrug developmenthospital-acquired bacterial pneumoniaventilator-associated bacterial pneumonia

Identifiers

PMID37740559
PMCPMC10874265
OpenAlexW4386979570

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.