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CTRI Number  CTRI/2024/12/078631 [Registered on: 27/12/2024] Trial Registered Prospectively
Last Modified On: 15/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Risks of severe lung infection among pneumonia patients admitted to the hospital. 
Scientific Title of Study   Clinical, metabolomic, and genomic predictors of acute respiratory distress syndrome in hospitalized patients with community-acquired pneumonia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Souvik Chaudhuri 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Critical Care Medicine, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, District Udupi

Udupi
KARNATAKA
576104
India 
Phone  9937178620  
Fax    
Email  souvik.chaudhuri@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitin Gupta 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Infectious Diseases, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, District Udupi

Udupi
KARNATAKA
576104
India 
Phone  9868996079  
Fax    
Email  nitin.gupta@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Souvik Chaudhuri 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Critical Care Medicine, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, District Udupi

Udupi
KARNATAKA
576104
India 
Phone  9937178620  
Fax    
Email  souvik.chaudhuri@manipal.edu  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, V. Ramalingaswami Bhavan, P.O Box No. 4911, Ansari Nagar, New-Delhi 110029, India 
 
Primary Sponsor  
Name  Dr Souvik Chaudhuri 
Address  Department of Critical Care Medicine, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Pin 576104, Manipal, Karnataka 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Souvik Chaudhuri  Kasturba Hospital, Manipal  ICU-1,2,3 Department of Critical Care Medicine, First floor, Trauma and Emergency block
Udupi
KARNATAKA 		 9937178620

souvik.chaudhuri@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J189||Pneumonia, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Diagnosis of community-acquired pneumonia.
2. Pneumonia patients recruited within 24 hours of hospitalization.
 
 
ExclusionCriteria 
Details  1. Patients hospitalized for more than 48 hours, who could be at risk of hospital-acquired pneumonia.
2. Pulmonary tuberculosis, pulmonary tumours, interstitial lung disease, pulmonary oedema, pulmonary embolism
3. Patients with a history of hospitalization for ≥ 2 days in another hospital before current admission.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Acute Respiratory Distress Syndrome  48 hours after hospitalization 
 
Secondary Outcome  
Outcome  TimePoints 
Mortality  14 days after hospital admission 
Acute Respiratory Distress Syndrome  7 days after hospital admission 
 
Target Sample Size   Total Sample Size="418"
Sample Size from India="418" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

1.      Patients will be recruited after written informed consent from patients/ legally acceptable representatives.

2.     Demographic profile of community acquired pneumonia (CAP) patient, Charlson co-morbidity index score, baseline vitals at hospitalization, and Sequential Organ Failre Assessment (SOFA) score, Pneumonia Severity Index (PSI) score, CURB-65 score, and NEWS-2 score will be recorded. Chest radiographs (CXR) will be evaluated for the worst Brixia CXR score within 24 hours. A bedside point of care ultrasound examination of the lungs will be performed. APACHE-2 score will be recorded for patients in ICU, which is standard practice. The worst SOFA score, PSI score, CURB-65 score, and NEWS- 2 score and Brixia chest x-ray score with 48 hours of hospital stay will be noted.

3.   Blood samples will be obtained within 24 hours for the analysis of the pulmonary biomarkers and metabolomic study. The biomarkers evaluated will be along with three novel pulmonary biomarkers – surfactant protein-D (SP-D), Angiopoietin-2 (Ang-2) and soluble receptor for advanced glycation end products (sRAGE).

4.  For metabolomics the study will be in Biochemistry laboratory using GC-MS coupled with a Shimadzu Mass Spectrometer (MS) (GC/MS -QP2020 NX SHIMADZU, Shimadzu Corp., Tokyo, Japan). Lipid, ketone body, fatty acid, energy, amino acid and organic acid metabolomics will be studied, with a total of about 160 metabolites.

5.    For the genome sequencing study, blood samples will be transported in dry ice blood to the Department of Medical Genetics and Kasturba Medical College, Manipal. Samples will then be outsourced to Medgenome company for Genome Wide Association Study and SNPs identification. Further GWAS analysis will be performed in Department of Medical Genetics and Kasturba Medical College, Manipal.

6.  Standard of care investigations like blood picture, coagulation profiles, tests of renal and liver function, c-reactive protein, procalcitonin, and arterial blood gas reports, will be noted from the available recorded data for 48 hours post hospitalization. The echocardiography findings will be noted from the records. The available microbiological culture reports will be followed up for the respiratory or blood specimens. Mode of ventilation and ventilator parameters will also be recorded like plateau pressure, driving pressure, positive end expiratory pressure, and peak pressure.

7.  Patients will be noted for ARDS development within the 48 hours of hospitalization and from the third to seventh-day post hospitalization, need for mechanical ventilation, days of ICU stay, need for renal replacement therapy in ICU, and development of acute kidney injury.

8.   Survival or mortality at 14 days post-hospitalization will be recorded.

 
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