| CTRI Number |
CTRI/2025/08/092812 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pneumonia, a lung infection |
|
Scientific Title of Study
|
Precision in Severe Pneumonia Management (PRISM) |
| Trial Acronym |
PRISM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raja Dhar |
| Designation |
Director and Head |
| Affiliation |
The Calcutta Medical Research Institute |
| Address |
Department of Pulmonology
The Calcutta Medical Research Institute
7/2 Diamond Harbour Road
Kolkata-700027,West Bengal,India
Kolkata
WEST BENGAL
700027
India |
| Phone |
03340904090 |
| Fax |
|
| Email |
pulmoresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrita Bhattacharyya |
| Designation |
Consultant and Head, Respiratory Intensive Care Unit, |
| Affiliation |
The Calcutta Medical Research Institute |
| Address |
Department of Respiratory Intensive Care Unit,Level 4
The Calcutta Medical Research Institute
7/2 Diamond Harbour Road
Kolkata-700027,West Bengal,India
Kolkata
WEST BENGAL
700027
India |
| Phone |
9919645454 |
| Fax |
|
| Email |
pupuldoc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Bhattacharyya |
| Designation |
Consultant and Head, Respiratory Intensive Care Unit, |
| Affiliation |
The Calcutta Medical Research Institute |
| Address |
Department of Respiratory Intensive Care Unit,Level 4
The Calcutta Medical Research Institute
7/2 Diamond Harbour Road
Kolkata-700027,West Bengal,India
Kolkata
WEST BENGAL
700027
India |
| Phone |
9919645454 |
| Fax |
|
| Email |
pupuldoc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Raja Dhar |
| Address |
The Calcutta Medical Research Institute
7/2 Diamond Harbour Road
Kolkata-700027,West Bengal,India
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| D Praveen Valsalan |
Aster Medicity |
Department of Pulmonary Medicine, Ground floor, Kuttisahib Road Cheranelloor,South Chittor,Kochi, Kerala-682027
Ernakulam
KERALA |
9496072264
drpraveenvk@gmail.com |
| Dr Raja Dhar |
The Calcutta Medical Research Institute |
Department of Pulmonology,Level 4
7/2 Diamond Harbour Road
Kolkata-700027
Kolkata
WEST BENGAL |
03340904090
pulmoresearch@gmail.com |
| Dr Hari Kishan Gonuguntia |
Yashoda Hospital |
Behind Hari Hara Kala Bhavan, Secunderabad-500003
Hyderabad
TELANGANA |
8106403713
harikishnag@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Aster Medicity |
Approved |
| Institutional Ethics Committee,The calcutta Medical Research Institute |
Approved |
| Institutional Ethics Committee,Yashoda Academy of medical Education and Research |
Submittted/Under Review |
| Max HealthcareEthics Committee |
Approved |
| Narayana Health Academic Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J17||Pneumonia in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional respiratory sample, here its broncho alveolar lavage(BAL) |
After getting BAL Culture/sensitivity test report proper antibiotics would be administered. |
| Intervention |
The FilmArray Pneumonia Panel plus is a diagnostic kit |
This kit utilizes multiplex PCR technology to rapidly identify multiple pathogens associated with pneumonia, including bacteria, viruses, and certain antimicrobial resistance genes, directly from respiratory samples. It is a molecular diagnostic tool designed to aid in the diagnosis and management of lower respiratory tract infections. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults presenting with severe CAP (as defined by the CURB-65 score
2.BAL in the 1st 72 hrs of admission. |
|
| ExclusionCriteria |
| Details |
1. On palliative care
2. Ventilated at another centre |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients receiving appropriate antibiotic escalation/de-escalation at 24 hours post randomisation |
at 24 hours post randomization |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Adults presenting with severe CAP (as defined by the CURB-65 score )
2.Comparison of ancillary tests
3.Epidemiology of antibiotic resistance genes for bacteria causing co infections as well as primary pneumonia
4.Comparison of time to optimization of antibiotics ( biofire based ) as compared to positive cultures when available
|
At discharge points |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/08/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Community-acquired pneumonia (CAP) remains a
significant cause of ICU admissions worldwide, with viruses contributing
substantially to the disease burden. Coinfections with bacteria and viruses further
complicate the course and outcomes of patients with viral pneumonia. Pathogen
detection rates—and consequently the effectiveness of our empiric regimens,
especially concerning drug resistance—remain uncertain. The advent of multiplex
PCR techniques with antimicrobial resistance gene detection offers a promising
alternative. While these methods provide quicker results and greater
sensitivity than conventional techniques, their impact on pragmatic,
patient-centered outcomes is still unclear. Evaluating the utility of novel
multiplex PCR for pathogen and resistance gene detection within the Indian
population is essential. This study aims to determine whether multiplex PCR for
severe pneumonia can improve clinical outcomes in our setting. |