UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of short-course antibiotics for nursing and healthcare-associated pneumonia: a systematic review and meta-analysis
Acronym	Efficacy and safety of short-course antibiotics for nursing and healthcare-associated pneumonia: a systematic review and meta-analysis
Scientific Title	Efficacy and safety of short-course antibiotics for nursing and healthcare-associated pneumonia: a systematic review and meta-analysis
Scientific Title:Acronym	Efficacy and safety of short-course antibiotics for nursing and healthcare-associated pneumonia: a systematic review and meta-analysis
Region	Japan

Condition
Condition	Patients with nursing and healthcare-associated pneumonia (NHCAP) or healthcare-associated pneumonia (HCAP)
Classification by specialty	Pneumology Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to perform systematic review and meta-analysis to evaluate the efficacy of short-term (within one week) antibiotic treatment strategy for patients with nursing and healthcare-associated pneumonia (NHCAP) or healthcare-associated pneumonia (HCAP).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The cure rate for 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	Patients with nursing and healthcare-associated pneumonia (NHCAP) as defined by the 2017 JRS guidelines or healthcare-associated pneumonia (HCAP) as defined by the 2005 ATS/IDSA guidelines.
Key exclusion criteria	Pediatric patient
Target sample size

Research contact person
Name of lead principal investigator	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	135-8577
Address	5-1-38, Toyosu, Koto-ku, Tokyo, Japan
TEL	03-6204-6000
Email	y.f.0423@med.showa-u.ac.jp

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	135-8577
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	Showa University Koto Toyosu Hospital, Department of medicine, Division of Respiratory medicine and Allergology
Institute
Department

Funding Source
Organization	None.
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	Showa University Koto Toyosu Hospital, Department of medicine, Division of Respiratory medicine and Allergology
Address	5-1-38, Toyosu, Koto-ku, Tokyo, Japan
Tel	03-6204-6000
Email	y.f.0423@med.showa-u.ac.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 08 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	Completed
Date of protocol fixation	2022 Year 08 Month 01 Day
Date of IRB	2022 Year 07 Month 01 Day
Anticipated trial start date	2022 Year 09 Month 01 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. Search methods 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. Assessing the risk of bias To assess the risk of bias, we will use the Risk of Bias 2 tool for RCTs and Newcasstle-Ottawa scale 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 3. Meta-analysis Meta-analysis will be performed using statistical software, such as Review Manager 5.3.5, R, and STATA. 4. Sensitivity analysis Sensitivity analysis and subgroup analysis will be performed as needed based on the results of the adopted literature. 5. Summary of findings table SOF tables will be created for the following outcomes. Primary outcomes: 1. The cure rate for pneumonia Secondary outcomes: 1. Survival rate 2. Adverse events 3. Length of hospital stay 4. Hospital readmission 5. Cost 6. Incidence of drug-resistant bacteria

Management information
Registered date	2022 Year 08 Month 04 Day
Last modified on	2022 Year 12 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055312