UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049116 |
|---|---|
| Receipt number | R000055843 |
| Scientific Title | Risk factors for drug-resistant pathogens in community-onset pneumonia: a systematic review and meta-analysis |
| Date of disclosure of the study information | 2022/10/04 |
| Last modified on | 2022/12/12 09:19:11 |
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Basic information
Public title
Risk factors for drug-resistant pathogens in community-onset pneumonia: a systematic review and meta-analysis
Acronym
Risk factors for drug-resistant pathogens in community-onset pneumonia: a systematic review and meta-analysis
Scientific Title
Risk factors for drug-resistant pathogens in community-onset pneumonia: a systematic review and meta-analysis
Scientific Title:Acronym
Risk factors for drug-resistant pathogens in community-onset pneumonia: a systematic review and meta-analysis
Region
| Japan |
Condition
Condition
community-onset pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to identify risk factors for drug-resistant pathogens in community-onset pneumonia.
Basic objectives2
Others
Basic objectives -Others
This study aims to identify risk factors for drug-resistant pathogens in community-onset pneumonia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
risk factors for drug-resistant pathogens in community-onset pneumonia
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This systematic review will target participants as follows: Adult patients with community-acquired pneumonia as defined by an official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America 2019; Adult patients with nursing and healthcare-associated pneumonia as defined by an official clinical practice guideline of the Japanese Respiratory Society 2017. Study designs for eligible studies will be RCTs and observational studies. Drug-resistant bacteria are defined as "pathogens such as Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus, Acinetobacter baumannii, Stenotrophomonas maltophilia, and ESBL-producing Enterobacteriaceae that are not sensitive to beta-lactam antibiotics, macrolides, or respiratry quinolones. Stenotrophomonas maltophilia ESBL-producing Enterobacteriaceae, and other pathogens".
Key exclusion criteria
Pediatric patients under 18 years of age and adult patients with hospital-acquired pneumonia and ventilator-associated pneumonia as defined by an official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America 2016
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Katsurada |
Organization
Kita-Harima Medical Center
Division name
Department of Respiratory Medicine
Zip code
675-1392
Address
926-250, Ono, Hyogo, Japan
TEL
0794-88-8800
pgex309t@gmail.com
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Fukuda |
Organization
Showa University Koto Toyosu Hospital
Division name
Department of medicine, Division of Respiratory medicine and Allergology
Zip code
1358577
Address
5-1-38, Toyosu, Koto-ku, Tokyo, Japan
TEL
03-6204-6000
Homepage URL
y.f.0423@med.showa-u.ac.jp
Sponsor or person
Institute
Japan 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
| 2022 | Year | 10 | Month | 04 | 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
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
Preinitiation
Date of protocol fixation
| 2022 | Year | 10 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | 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 Cochrane Central Resister of Controlled Trials (CENTRAL); MEDLINE via Ovid. Additionally, we will also search the other resources; the World health Organization International Clinical Trials Platform Search Portal (ICTRP) and ClinicalTrials.gov.
2. Meta-analysis will be performed using statistical software, such as Review Manager 5.3.5, R, and STATA.
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. Two 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 risk factors for drug-resistant pathogens.
Management information
Registered date
| 2022 | Year | 10 | Month | 04 | Day |
Last modified on
| 2022 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055843
