UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046236
Receipt number R000049197
Scientific Title Analysis of Bronchoalveolar Lavage to Assess Local Immunopathology in Severe Pneumonia (Focus on sTREM, Alveolar Macrophage, IL-6, IL-17, CD4, T-reg, Surfactant Protein-A, and Caspase-3)
Date of disclosure of the study information 2021/11/30
Last modified on 2022/04/18 14:48:15

* 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

Analysis of Bronchoalveolar Lavage to Assess Local Immunopathology

Acronym

ABLALI

Scientific Title

Analysis of Bronchoalveolar Lavage to Assess Local Immunopathology in Severe Pneumonia (Focus on sTREM, Alveolar Macrophage, IL-6, IL-17, CD4, T-reg, Surfactant Protein-A, and Caspase-3)

Scientific Title:Acronym

ABLALISP

Region

Asia(except Japan)


Condition

Condition

Severe Pneumonia

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine differences of local immunopathology response between right and left lung of severe pneumonia patients

Basic objectives2

Others

Basic objectives -Others

To assess immunopathology response differences in severe pneumonia patients with extubation failure and mortality

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Extubation failure at 19 days

Key secondary outcomes

Mortality after 28 days


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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

18 years or older, severe pneumonia according to IDSA/ATS criteria, can undergo bronchoscopy within 12 hours, received empirical antibiotics in less than 24 hours, intubated within < 24 hours

Key exclusion criteria

non-infectious acute respiratory distress syndrome, HIV/AIDS, active malignancy within 12 months, under immunosuppressants, refuse to undergo bronchoscopy

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Gurmeet
Middle name
Last name Singh

Organization

Indonesian Doctors Association

Division name

Respirology and Critical Care

Zip code

13310

Address

Jl. Diponegoro No. 71

TEL

081385158159

Email

gurmeetsingh10@yahoo.com


Public contact

Name of contact person

1st name Gurmeet
Middle name
Last name Singh

Organization

Indonesian Doctors Association

Division name

Respirology and Critical Care

Zip code

13310

Address

Jl. Diponegoro No. 71

TEL

081385158159

Homepage URL


Email

gurmeetsingh10@yahoo.com


Sponsor or person

Institute

PERPARI - Indonesian Respirology Society

Institute

Department

Personal name



Funding Source

Organization

PERPARI - Indonesian Respirology Society

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Universitas Indonesia

Address

Jl. Salemba No. 6 Jakarta

Tel

0213157008

Email

ec_fkui@yahoo.com


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

2021 Year 11 Month 30 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

40

Results

There was a significance difference on local immunopathology response of CD4 BAL between right and left lung of severe pneumonia patients (p = 0,003). There was a significance difference of CD4 BAL in severely affected lung on extubation 19 days (p = 0,01) and mortality 28 days (p = 0,004). There were kinetic interactions between alveolar macrophage function, IL-6, IL-17, CD4, and Treg in severely affected lung on the extubation and mortality status.

Results date posted

2021 Year 11 Month 30 Day

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

2020 Year 02 Month 17 Day

Date of IRB

2020 Year 02 Month 17 Day

Anticipated trial start date

2020 Year 07 Month 24 Day

Last follow-up date

2020 Year 10 Month 17 Day

Date of closure to data entry

2020 Year 10 Month 20 Day

Date trial data considered complete

2021 Year 01 Month 17 Day

Date analysis concluded

2021 Year 11 Month 03 Day


Other

Other related information

Admitted ER patients who fulfilled inclusion criteria or hospitalized at ICU accepted the informed consent for the researcher to collect the data (based on research form). Bronchoscopy will then be conducted within 12 hours for specimen collection in the right and left lung. Patients then were observed for 19 days to assess the extubation status and will be continued for 28 days for the mortality status.


Management information

Registered date

2021 Year 11 Month 30 Day

Last modified on

2022 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049197


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name