UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055978 |
|---|---|
| Receipt number | R000063972 |
| Scientific Title | An observational study on the association between oral microflora and ventilator-associated pneumonia in Vietnam |
| Date of disclosure of the study information | 2024/10/29 |
| Last modified on | 2025/05/01 14:43:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
An observational study on the association between oral microflora and ventilator-associated pneumonia in Vietnam
Acronym
Oral microbiome study
Scientific Title
An observational study on the association between oral microflora and ventilator-associated pneumonia in Vietnam
Scientific Title:Acronym
Oral microbiome study
Region
| Japan | Asia(except Japan) |
Condition
Condition
ventilator-associated pneumonia
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Determine differences in oral microbiota in intubated patients with and without ventilator-associated pneumonia.
Basic objectives2
Others
Basic objectives -Others
Determining the relationship between bacterial flora in sputum and oral cavity specimens in patients with mechanically ventilated pneumonia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in oral flora in intubated patients with and without VAP using real-time PCR: during the first 7 days from case enrollment
Key secondary outcomes
Aassociation of bacterial flora in sputum and oral specimens in patients with VAP
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 18 years of age or older
2) Patients who are intubated within 48 hours of admission and who will be admitted to the ICU within 48 hours of admission
3) Patients who have obtained consent to participate in the study from the patient or a surrogate
Key exclusion criteria
1) Patients with pneumonia prior to intubation
2) Patients who have been extubated/left ICU/deceased within 48 hours of intubation
3) Patients with trauma to the head, neck, or face
4) Patients whose oral cavity is contaminated with blood
5) Patients with trauma or signs of infection in the oral cavity prior to intubation
6) Those who are judged as unsuitable by the principal investigator or the project leader
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Saito |
Organization
Japan Institute for Health Security
Division name
Disease Control and Prevention Center
Zip code
162-8655
Address
1-21-1 Toyama Shinjuku-ku, Tokyo, Japan
TEL
0332027181
saito.s@jihs.go.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Saito |
Organization
Japan Institute for Health Security
Division name
Disease Control and Prevention Center
Zip code
162-8655
Address
1-21-1 Toyama Shinjuku-ku, Tokyo, Japan
TEL
0332027181
Homepage URL
oralmicroflora@jihs.go.jp
Sponsor or person
Institute
Japan Institute for Health Security
Institute
Department
Personal name
Funding Source
Organization
SUNSTAR INC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board of Japan Institute for Health Security
Address
1-21-1 Toyama Shinjuku-ku, Tokyo 162-8655, Japan
Tel
03-3202-7181
kenkyu-shinsa@jihs.go.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
Cho Ray Hospital (Ho Chi Minh City, Vietnam)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The prospective observational study will be conducted to evaluate the association between changes in oral flora and the occurrence of VAP in intubated patients.
The subjects will be patients admitted to the CRH who are (1) intubated within 48 hours of admission and (2) admitted to the ICU within 48 hours of admission.
During the observation period, oral wipes will be collected every day from day0-day7. Day8-day10 will be observed for the occurrence of VAP.
We will compare the total number of bacteria and alpha-diversity of oral specimens between the group that had VAP (VAP group) and the group that did not have VAP (non-VAP group) during the observation period to identify factors related to VAP in the oral microflora.
Management information
Registered date
| 2024 | Year | 10 | Month | 29 | Day |
Last modified on
| 2025 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063972
