Exploration of a Potential DOOR Endpoint for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Using Six Registrational Trials for Antibacterial Drugs
Published by Oxford University Press on behalf of Infectious Diseases Society of America 2024..
BACKGROUND: Desirability 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).
METHODS: Through comprehensive examination of data from nearly 4,000 participants enrolled in six registrational trials for HABP/VABP submitted to the FDA between 2005-2022, 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.
RESULTS: DOOR 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. Though infectious complications and serious adverse events occurred more frequently in ventilated participants compared to non-ventilated participants, the types of events were similar.
CONCLUSIONS: Through 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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
|---|---|
| Enthalten in: |
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America - (2024) vom: 25. März |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Kinamon, Tori [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Antimicrobial therapy |
|---|
| Anmerkungen: |
Date Revised 25.03.2024 published: Print-Electronic Citation Status Publisher |
|---|
| doi: |
10.1093/cid/ciae163 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM370174089 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM370174089 | ||
| 003 | DE-627 | ||
| 005 | 20240327000553.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240327s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1093/cid/ciae163 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1349.xml |
| 035 | |a (DE-627)NLM370174089 | ||
| 035 | |a (NLM)38527855 | ||
| 035 | |a (PII)ciae163 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Kinamon, Tori |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Exploration of a Potential DOOR Endpoint for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Using Six Registrational Trials for Antibacterial Drugs |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 25.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a Published by Oxford University Press on behalf of Infectious Diseases Society of America 2024. | ||
| 520 | |a BACKGROUND: Desirability 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) | ||
| 520 | |a METHODS: Through comprehensive examination of data from nearly 4,000 participants enrolled in six registrational trials for HABP/VABP submitted to the FDA between 2005-2022, 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 | ||
| 520 | |a RESULTS: DOOR 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. Though infectious complications and serious adverse events occurred more frequently in ventilated participants compared to non-ventilated participants, the types of events were similar | ||
| 520 | |a CONCLUSIONS: Through 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a DOOR | |
| 650 | 4 | |a antimicrobial therapy | |
| 650 | 4 | |a clinical trials | |
| 650 | 4 | |a hospital-acquired bacterial pneumonia | |
| 650 | 4 | |a ventilator-associated bacterial pneumonia | |
| 700 | 1 | |a Waack, Ursula |e verfasserin |4 aut | |
| 700 | 1 | |a Needles, Mark |e verfasserin |4 aut | |
| 700 | 1 | |a Rubin, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a Collyar, Deborah |e verfasserin |4 aut | |
| 700 | 1 | |a Doernberg, Sarah B |e verfasserin |4 aut | |
| 700 | 1 | |a Evans, Scott R |e verfasserin |4 aut | |
| 700 | 1 | |a Hamasaki, Toshimitsu |e verfasserin |4 aut | |
| 700 | 1 | |a Holland, Thomas L |e verfasserin |4 aut | |
| 700 | 1 | |a Howard-Anderson, Jessica |e verfasserin |4 aut | |
| 700 | 1 | |a Chambers, Henry |e verfasserin |4 aut | |
| 700 | 1 | |a Fowler, Vance G |c Jr |e verfasserin |4 aut | |
| 700 | 1 | |a Nambiar, Sumati |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Boucher, Helen W |e verfasserin |4 aut | |
| 700 | 1 | |a Gopinath, Ramya |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Clinical infectious diseases : an official publication of the Infectious Diseases Society of America |d 1992 |g (2024) vom: 25. März |w (DE-627)NLM012603007 |x 1537-6591 |7 nnns |
| 773 | 1 | 8 | |g year:2024 |g day:25 |g month:03 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1093/cid/ciae163 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |j 2024 |b 25 |c 03 | ||