UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026457 |
|---|---|
| Receipt number | R000030392 |
| Scientific Title | Impact of Gram stain results on initial treatment selection in patients with ventilator-associated pneumonia: a retrospective analysis of two treatment algorithms |
| Date of disclosure of the study information | 2017/03/08 |
| Last modified on | 2017/03/08 11:34:43 |
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Basic information
Public title
Impact of Gram stain results on initial treatment selection in patients with ventilator-associated pneumonia: a retrospective analysis of two treatment algorithms
Acronym
Impact of Gram stain results on initial treatment selection in patients with ventilator-associated pneumonia: a retrospective analysis of two treatment algorithms
Scientific Title
Impact of Gram stain results on initial treatment selection in patients with ventilator-associated pneumonia: a retrospective analysis of two treatment algorithms
Scientific Title:Acronym
Impact of Gram stain results on initial treatment selection in patients with ventilator-associated pneumonia: a retrospective analysis of two treatment algorithms
Region
| Japan |
Condition
Condition
ventilator-associated penumonia
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate whether a Gram stain of endotracheal aspirates could be used to determine appropriate initial antimicrobial therapy for VAP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The coverage rates of initial antimicrobial therapies.
Key secondary outcomes
The selected rates of anti-pseudomonal agents and anti-MRSA agents
Base
Study type
Observational
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were treated for ventilator-associated pneumonia were eligible for this study.
Key exclusion criteria
modified clinical pulmonary infection score (CPIS) less than 5.
semi-quantitative growth of a respiratory pathogen using a respiratory sample was estimated to be less than 1+.
Target sample size
219
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Fujimi |
Organization
Osaka General Medical Centre
Division name
Division of Trauma and Surgical Critical Care
Zip code
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka 558-8558, Japan
TEL
06-6692-1201
fujimis@opho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Kinoshita |
Organization
Osaka General Medical Centre
Division name
Division of Trauma and Surgical Critical Care
Zip code
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka 558-8558, Japan
TEL
06-6692-1201
Homepage URL
ogmc.dmat.t.kinoshita@gmail.com
Sponsor or person
Institute
Osaka General Medical Centre
Institute
Department
Personal name
Funding Source
Organization
Osaka General Medical Centre
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
Address
Tel
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
| 2017 | Year | 03 | Month | 08 | 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
Antimicrobial choices proposed by the Guideline based algorithm and the Gram stain based algorithm were appropriate in 94.7% and 92.4% of cases, respectively. McNemar's test showed no significant difference in adequacy for the different strategies (p = 0.221). The Gram stain based algorithm proposed anti-methicillin-resistant Staphylococcus aureus agents in significantly fewer episodes than the Guideline based algorithm (41 (31.3%) versus 92 (70.2%), respectively (p < 0.001)). The Gram stain based algorithm also recommended antipseudomonal agents in significantly fewer episodes than the Guideline based algorithm (68 (51.9%) versus 92 (70.2%), respectively (p < 0.001)).
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
| 2016 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 22 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 22 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 22 | Day |
Date analysis concluded
| 2017 | Year | 02 | Month | 01 | Day |
Other
Other related information
To evaluate whether Gram stain of endotracheal aspirate was a reliable guide for the selection of antimicrobial therapy for VAP, we constructed 2 hypothetical empirical antimicrobial treatment algorithms: a guidelines-based algorithm (GLBA) and a Gram stain-based algorithm (GSBA). Both the GLBA and the GSBA were hypothetically applied to the same VAP episodes and the antimicrobial agents proposed by each algorithm were compared retrospectively. Therapy was considered appropriate when all pathogens involved in the VAP episode were covered by antimicrobial agents.
Management information
Registered date
| 2017 | Year | 03 | Month | 08 | Day |
Last modified on
| 2017 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030392
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