UMIN-CTR Clinical Trial

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
Email	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
Email	y.f.0423@med.showa-u.ac.jp

Sponsor
Institute	Japan Respiratory Society
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055843