UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057547 |
|---|---|
| Receipt number | R000065753 |
| Scientific Title | Utility of risk assessment and identification of risk factors for drug-resistant pathogens in hospital-acquired and ventilator-associated pneumonia: Systematic reviews and meta-analyses |
| Date of disclosure of the study information | 2025/04/08 |
| Last modified on | 2025/04/08 01:24:15 |
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Basic information
Public title
Utility of risk assessment and identification of risk factors for drug-resistant pathogens in hospital-acquired and ventilator-associated pneumonia: Systematic reviews and meta-analyses
Acronym
Utility of risk assessment and identification of risk factors for drug-resistant pathogens in hospital-acquired and ventilator-associated pneumonia: Systematic reviews and meta-analyses
Scientific Title
Utility of risk assessment and identification of risk factors for drug-resistant pathogens in hospital-acquired and ventilator-associated pneumonia: Systematic reviews and meta-analyses
Scientific Title:Acronym
Utility of risk assessment and identification of risk factors for drug-resistant pathogens in hospital-acquired and ventilator-associated pneumonia: Systematic reviews and meta-analyses
Region
| Japan |
Condition
Condition
Hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the first is to assess differences in outcomes between patients with high- and low-risk for DR pathogens in HAP/VAP, and the second seeks to comprehensively identify risk factors for DR pathogens in HAP/VAP.
Basic objectives2
Others
Basic objectives -Others
The aim of the first is to assess differences in outcomes between patients with high- and low-risk for DR pathogens in HAP/VAP, and the second seeks to comprehensively identify risk factors for DR pathogens in HAP/VAP.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk factors for drug-resistant pathogens in HAP/VAP
Key secondary outcomes
Assessment the differences in outcomes between patients with high- and low-risk for drug-resistant pathogens in HAP/VAP
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In the systematic review and meta-analysis assessing the differences in outcomes between high- and low-risk patients, studies which met all three of the following inclusion criteria are considered eligible: (1) prospective studies in patients with HAP/VAP according to the 2005 ATS/IDSA guidelines which (2) evaluated the risk factors for DR pathogens and (3) reported the rates of each of the following according to a binary (high/low) risk classification: DR pathogen detection, inadequate empirical treatment, initial nonresponse to treatment, length of intensive care unit (ICU) stay, length of hospital stay, 30-day mortality, and hospital mortality. For any studies that did not classify high- and low-risk by the number of risk factors, we quantify the risk factors and define the high-risk as having >=2 risk factors.
In the other systematic review and meta-analysis for comprehensive identification of risk factors for DR pathogens in HAP and VAP, studies meeting both of the following criteria are eligible: (1) prospective studies evaluating the risk factors for DR in HAP and VAP that (2) studies employing a multivariate analysis for identifying risk factors associated with DR pathogens. Studies that performed only univariate analyses are excluded because they usually contain inflated association measures.
Key exclusion criteria
Exclusion criteria in the above two systematic reviews and meta-analyses are as follows: (1) studies that included only paediatric populations (<15 years old); (2) studies that included only VAP patients or did not exclude community-acquired pneumonia (CAP) or healthcare-associated pneumonia (HCAP) as defined by the 2005 ATS/IDSA guidelines; (3) studies that included only pathogen-specific pneumonia; (4) case reports or reviews; (5) conference presentations; and (6) studies with duplicated eligible patients, such as studies with overlapping periods at the same medical institution.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Yamamoto |
Organization
University of Toyama
Division name
Department of Clinical Infectious Diseases
Zip code
930-0194
Address
2630 Sugitani, Toyama, Japan
TEL
076-434-2281
yamamoto@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kawasuji |
Organization
University of Toyama
Division name
Department of Clinical Infectious Diseases
Zip code
930-0194
Address
2630 Sugitani, Toyama, Japan
TEL
076-434-2281
Homepage URL
kawasuji@med.u-toyama.ac.jp
Sponsor or person
Institute
The Japanese Respiratory Society
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Japanese Respiratory Society
Address
8-28-3 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5805-3553
info@jrs.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
1645
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. A systematic search of the literature will be conducted according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) Statement. We will search the following electrical databases; the PubMed, Web of Science, Cochrane Library, ClinicalTrials.gov, and Ichushi Web databases.
2. Meta-analysis will be performed using statistical software, such as Review Manager 5.4.
3. To assess the risk of bias, we will use the Risk of Bias 1 tool for RCTs and Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS) for non-RCT/ Observational studies. Four reviewers will independently screen the full text of each study and decide whether the studies met the inclusion criteria. Any disagreement will be resolved by discussion or consulting the third reviewer. We will assess heterogeneity by using the I2 statistical method and publication bias using funnel plot.
4. Sensitivity analysis and subgroup analysis will be performed as needed based on the results of the adopted literature.
5. Forest plots will be created for the differences in outcomes between high- and low-risk patients and risk factors for drug-resistant pathogens.
Management information
Registered date
| 2025 | Year | 04 | Month | 08 | Day |
Last modified on
| 2025 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065753
