UMIN-CTR Clinical Trial

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
Institute	PERPARI - Indonesian Respirology Society
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049197