Evidence map›Paper›PMID 38527855›Full record

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

Exploration of a Potential DOOR Endpoint for Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Using Six Registrational Trials for Antibacterial Drugs.

Tori Kinamon, Ursula Waack, Mark Needles, Daniel Rubin, Deborah Collyar, Sarah B Doernberg, Scott R Evans, Toshimitsu Hamasaki, Thomas L Holland, Jessica Howard-Anderson and 6 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
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. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
3.4field-weighted citation impact, top 7% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 3 citations in OpenAlex.

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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

16 authors at 10 institutions in 1 country.

Tori KinamonCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Ursula WaackCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0003-4517-6790
Mark NeedlesCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Daniel RubinCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Deborah CollyarPatient Advocates in Research, Danville, California, USA.
Sarah B DoernbergDepartment of Medicine, Division of Infectious Diseases, University of California San Francisco, San Francisco, California, USA.ORCID 0000-0003-1727-6014
Scott R EvansBiostatistics Center and Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, George Washington University, Washington D.C., USA.ORCID 0000-0003-3186-172X
Toshimitsu HamasakiBiostatistics Center and Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, George Washington University, Washington D.C., USA.
Thomas L HollandDepartment of Medicine, Duke University Medical Center, Durham, North Carolina, USA.
Jessica Howard-AndersonAntibacterial Resistance Leadership Group, Durham, North Carolina, USA.
Henry ChambersDepartment of Medicine, Division of Infectious Diseases, University of California San Francisco, San Francisco, California, USA.
Vance G FowlerDepartment of Medicine, Duke University Medical Center, Durham, North Carolina, USA.
Sumati NambiarAntibacterial Resistance Leadership Group, Durham, North Carolina, USA.
Peter KimCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Helen W BoucherAntibacterial Resistance Leadership Group, Durham, North Carolina, USA.
Ramya GopinathCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
United States Food and Drug Administration · USMilken Institute · USUniversity of California, San Francisco · USClinical Research Institute · USDuke Medical Center · USEmory University · USJohnson & Johnson (United States) · USOak Ridge Associated Universities · USOrthopaedic Research of Virginia · USTufts University · US

Funding

Antibacterial Resistance Leadership Group (ARLG)UM1AI104681 · NIAID · DUKE UNIVERSITY · PI Vance G. Fowler, Henry F HENRY CHAMBERS · 2013 to 2026
$180.8M
Antibacterial Resistance Leadership GroupARLG)Basilea PharmaceuticaFDANIAIDNIAID NIH HHS UM1 AI104681NIH
6 · The paper itself

Abstract

backgroundDesirability of outcome ranking (DOOR) is an innovative approach to clinical trial design and analysis that uses an ordinal ranking system to incorporate the overall risks and benefits of a therapeutic intervention into a single measurement. Here we derived and evaluated a disease-specific DOOR endpoint for registrational trials for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).

methodsThrough comprehensive examination of data from nearly 4000 participants enrolled in six registrational trials for HABP/VABP submitted to the Food and Drug Administration (FDA) between 2005 and 2022, we derived and applied a HABP/VABP specific endpoint. We estimated the probability that a participant assigned to the study treatment arm would have a more favorable overall DOOR or component outcome than a participant assigned to comparator.

resultsDOOR distributions between treatment arms were similar in all trials. DOOR probability estimates ranged from 48.3% to 52.9% and were not statistically different. There were no significant differences between treatment arms in the component analyses. Although infectious complications and serious adverse events occurred more frequently in ventilated participants compared to non-ventilated participants, the types of events were similar.

conclusionsThrough a data-driven approach, we constructed and applied a potential DOOR endpoint for HABP/VABP trials. The inclusion of syndrome-specific events may help to better delineate and evaluate participant experiences and outcomes in future HABP/VABP trials and could help inform data collection and trial design.

Indexed as

Anti-Bacterial AgentsPneumonia, BacterialPneumonia, Ventilator-AssociatedAgedClinical Trials as TopicCross InfectionFemaleHealthcare-Associated PneumoniaHumansMaleMiddle AgedTreatment OutcomeUnited StatesUnited States Food and Drug AdministrationAnti-Bacterial Agentsantimicrobial therapyclinical trialsDOORhospital-acquired bacterial pneumoniaventilator-associated bacterial pneumonia

Identifiers

PMID38527855
PMCPMC11259224
OpenAlexW4394758282

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.