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CTRI Number  CTRI/2024/03/063775 [Registered on: 07/03/2024] Trial Registered Prospectively
Last Modified On: 29/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational study 
Study Design  Single Arm Study 
Public Title of Study   Pneumonia in ICU - Multiplex PCR panel vs Semi Quantitative Cultures. 
Scientific Title of Study   To Evaluate the Concordance of Multiplex PCR Panel with Semi-Quantitative Cultures in Patients with Community Acquired Pneumonia, Hospital Acquired Pneumonia and Ventilator Associated Pneumonia in Intensive Care Units 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gowri Vishalakshi SM 
Designation  Senior Resident 
Affiliation  Max Superspeciality hospital, Saket 
Address  Department of Critical Care Medicine, 2nd floor, Neurointensive care and Stroke Unit, Max super speciality hospital, 1,2 press enclave Mark, Saket, New Delhi -110017

South
DELHI
110017
India 
Phone  8056747960  
Fax    
Email  gowrivishalakshi1905@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Omender Singh 
Designation  Principal Director  
Affiliation  Max Superspeciality hospital, Saket 
Address  Department of critical care medicine, 2nd floor, Neurointensive care and stroke unit, Max super speciality hospital, 1,2 press enclave Mark, Saket, New Delhi -110017

South
DELHI
110017
India 
Phone  9810734246  
Fax    
Email  omender.singh@maxhealthcare.com  
 
Details of Contact Person
Public Query
 
Name  Gowri Vishalakshi SM 
Designation  Senior Resident 
Affiliation  Max Superspeciality hospital, Saket 
Address  Department of critical care medicine, 2nd floor, Neurointensive care and stroke unit, Max super speciality hospital, 1,2 press enclave Mark, Saket, New Delhi -110017

South
DELHI
110017
India 
Phone  8056747960  
Fax    
Email  gowrivishalakshi1905@gmail.com  
 
Source of Monetary or Material Support  
Max Superspeciality hospital, Saket, New Delhi 
 
Primary Sponsor  
Name  Max Superspeciality hospital, Saket, New Delhi 
Address  Max Superspeciality Hospital, Saket, 1 press enclave Road, New Delhi -110017 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gowri Vishalakshi SM  Max Superspeciality hospital, Saket, New Delhi  OncoMedical Intensive Care Unit, second floor, Max Superspeciality hospital, East block, 1,2 press enclave, Saket, New Delhi -110017
South
DELHI 
8056747960

gowrivishalakshi1904@gmail.com 
Dr Gowri Vishalakshi SM  Max Superspeciality hospital, Saket, New Delhi  Medical ICU 6th floor, Max Superspeciality hospital, Saket, 1 press enclave road, New Delhi - 110017
South
DELHI 
8056747960

gowrivishalakshi1904@gmail.com 
Dr Gowri Vishalakshi SM  Max Superspeciality hospital, Saket, New Delhi  Medical ICU 5th floor, Max Superspeciality hospital, Saket, 1, press enclave road, New Delhi-110017
South
DELHI 
8056747960

gowrivishalakshi1904@gmail.com 
Dr Gowri Vishalakshi SM  Max Superspeciality hospital, Saket, New Delhi  Neurointensive care and stroke unit, 2nd floor, Max Superspeciality hospital, Saket, 1, press enclave, New Delhi-110017
South
DELHI 
8056747960

gowrivishalakshi1904@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee,Max superspeciality hospital, Saket, New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B949||Sequelae of unspecified infectiousand parasitic disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Male and female patients ≥18 years of age admitted in INtensive care unit with suspected or proven community acquired pneumonia, hospital acquired pneumonia or ventilator associated pneumonia, meeting the respective 2018 guidelines 
 
ExclusionCriteria 
Details  1) Patients below 18 years of age.
2) Patients who are unable to provide a respiratory sample for testing.
3) Active tuberculosis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Concordance or discordance of the bio fire pneumonia panel and cultures  Time of receipt of Culture and Sensitivity report 
 
Secondary Outcome  
Outcome  TimePoints 
Concordance or discordance of bio fire pneumonia panel with gram stain  Time of receipt of respiratory panel & gram stain report 
 
Target Sample Size   Total Sample Size="95"
Sample Size from India="95" 
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)   20/03/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Patients in ICU with suspected or proven pneumonia (CAP/HAP/VAP) will be considered for recruitment into the study. Patients who meet the inclusion criteria will be recruited in after written informed consent. Patients will be treated according to the standard of care in accordance with international guidelines [6, 10]. Respiratory tract samples will be collected and sent for Gram stain and semi-quantitative bacterial cultures and the multiplex PCR (BioFire® Filmarray®Pneumonia Panel) as per the orders of the primary treating physician. Respiratory samples may be non invasive (sputum) or invasive (BAL/endotracheal aspirate).  Respiratory samples will be transported to the microbiological laboratory within a time frame of 1 hour. Low quality samples containing 10 or more epithelial cells per low power field and <25 pus cells per low power field will be rejected. 

Other microbiological investigations such as S. pneumoniae and L. pneumophilia urine antigen assays, antibody blood testing with respiratory tract sample PCR for Chlamydia pneumonia and Mycoplasma pneumonia, respiratory tract sample PCR for Influenza will be done as per the requirements. Additional microbiological samples such as blood cultures, urine cultures, CSF cultures, pleural fluid cultures etc may be performed at the clinician’s discretion. All other biochemical and radiological investigations will be performed at the clinician’s discretion. All microbiological samples will be processed in the microbiology laboratory of our institute. 

Baseline SOFA, APACHE II and CPIS (in patients with VAP) will be calculated for all patients included in the study, at the time of inclusion into the study. Turnaround time for BioFire® Filmarray® Pneumonia Panel is the time interval between the receipt of sample at microbiology laboratory and the receipt of results. The FilmArray® PP results will be considered concordant if they are consistent with the results of cultures. Otherwise, the results of FilmArray® PP will be considered discordant.

A positive match of the Gram stain result with the result of FilmArray® PP will be considered concordant and the results will be considered discordant otherwise.

The data will be recorded in the proforma  and used for statistical analysis.

 
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