UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048776 |
|---|---|
| Receipt number | R000055570 |
| Scientific Title | Efficacy and safety of anti-MRSA antibiotics for hospital-acquired pneumonia: a systematic review and meta-analysis |
| Date of disclosure of the study information | 2022/08/27 |
| Last modified on | 2023/03/09 23:25:06 |
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Basic information
Public title
Efficacy and safety of anti-MRSA antibiotics for hospital-acquired pneumonia: a systematic review and meta-analysis
Acronym
Efficacy and safety of anti-MRSA antibiotics for hospital-acquired pneumonia: a systematic review and meta-analysis
Scientific Title
Efficacy and safety of anti-MRSA antibiotics for hospital-acquired pneumonia: a systematic review and meta-analysis
Scientific Title:Acronym
Efficacy and safety of anti-MRSA antibiotics for hospital-acquired pneumonia: a systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Hospital-acquired pneumonia
Classification by specialty
| Pneumology | Infectious disease | Intensive care medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this systematic review and meta-analysis is to evaluate the efficacy and safety of anti-MRSA (methicillin-resistant Staphylococcus aureus) antibiotics for hospital-acquired pneumonia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mortality (28-day, 30-day, or in-hospital)
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 hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP). HAP and VAP are defined as new-onset pneumonia after 48 hours of hospitalization according to ATS/IDSA 2016 and JRS 2017 guidelines.
Key exclusion criteria
None
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sugimoto |
Organization
NHO Kinki-chuo Chest Medical Center
Division name
Department of Internal Medicine
Zip code
591-8555
Address
1180 Nagasone-cho, Kita-ku, Sakai, Osaka, Japan
TEL
072-252-3021
dr.sugimoto@gmail.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sugimoto |
Organization
NHO Kinki-chuo Chest Medical Center
Division name
Department of Internal Medicine
Zip code
591-8555
Address
1180 Nagasone-cho, Kita-ku, Sakai, Osaka, Japan
TEL
072-252-3021
Homepage URL
dr.sugimoto@gmail.com
Sponsor or person
Institute
NHO Kinki-chuo Chest Medical Center
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
Not applicable
Address
Not applicable
Tel
Not applicable
Not applicable
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 | 27 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 27 | 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 strategy
A systematic review and meta-analysis will be conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. We will search the MEDLINE via PubMed, EMBASE via Dialog, and Cochrane Central Register of Controlled Trials (CENTRAL). In addition, the World Health Organization International Clinical Trials Platform Search Portal (ICTRP) and Clinical Trials.gov will be searched. We will also perform handsearching.
2. Study selection, Data collection, and Assessment of study quality
Two reviewers will independently screen all studies identified in the search strategy (duplicates will be removed), extract data from the eligible studies, and evaluate the risk of bias. Disagreements between the reviewers will resolve via discussion or by a third reviewer. To assess the risk of bias, we will use the Risk of Bias Tool for randomized controlled trials (RCTs) and ROBINS-I for non-RCTs.
3. Meta-analysis and summary of findings
Meta-analysis will be performed using statistical software, such as Review Manager, STATA, and R. We will also performed assessment of publication bias, sensitivity analysis, and subgroup analysis as necessary.
The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach will be used to assess the quality of evidence for each outcome. Summary of findings table will be made for the following outcomes.
Primary outcomes: Mortality (28-day, 30-day, or in-hospital)
Secondary outcomes:
(1) Cure rate for pneumonia
(2) Incidence of drug-resistant bacteria
(3) Adverse events
(4) Failure of empiric therapy
(5) Length of hospital stay
(6) Cost
Management information
Registered date
| 2022 | Year | 08 | Month | 27 | Day |
Last modified on
| 2023 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055570
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