| 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
|
|
|
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
|
|
|
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. |