UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048581 |
|---|---|
| Receipt number | R000055312 |
| Scientific Title | Efficacy and safety of short-course antibiotics for nursing and healthcare-associated pneumonia: a systematic review and meta-analysis |
| Date of disclosure of the study information | 2022/08/04 |
| Last modified on | 2022/12/05 10:05:43 |
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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
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
y.f.0423@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Koto Toyosu Hospital, Department of medicine, Division of Respiratory medicine and Allergology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055312
