| CTRI Number |
CTRI/2026/04/107709 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of a Rapid Pneumonia Diagnostic Test with Standard Laboratory Culture in ICU Patients and Its Impact on Antibiotic Treatment. |
|
Scientific Title of Study
|
COMPARATIVE ASSESSMENT OF BIOFIRE PNEUMONIA PANEL AND STANDARD CULTURE IN CRITICALLY ILL PNEUMONIA CASES AND ITS IMPACT ON ANTIMICROBIAL STEWARDSHIP |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MOHAMMED ZAHEER PASHA |
| Designation |
CLINICAL RESIDENT |
| Affiliation |
APOLLO BGS HOSPITAL MYSORE |
| Address |
4/B MANJUNATHA KRUPA, 2ND MAIN 9TH CROSS, SARASWATHIPURAM, MYSORE
Mysore
KARNATAKA
570009
India |
| Phone |
9742913961 |
| Fax |
|
| Email |
mzp.245@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GIRISH M |
| Designation |
CONSULTANT |
| Affiliation |
APOLLO BGS HOSPITAL MYSORE |
| Address |
DEPARTMENT OF CARDIAC ANESTHESIA AND CRITICAL CARE MEDICINE,
2ND FLOOR,
APOLLO BGS HOSPITAL,
ADICHUNCHANAGIRI ROAD,
MYSORE
Mysore
KARNATAKA
570023
India |
| Phone |
8884214484 |
| Fax |
|
| Email |
drgirish1703@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MOHAMMED ZAHEER PASHA |
| Designation |
CLINICAL RESIDENT |
| Affiliation |
APOLLO BGS HOSPITAL MYSORE |
| Address |
4/B MANJUNATHA KRUPA, 2ND MAIN 9TH CROSS, SARASWATHIPURAM, MYSORE
Mysore
KARNATAKA
570009
India |
| Phone |
9742913961 |
| Fax |
|
| Email |
mzp.245@gmail.com |
|
|
Source of Monetary or Material Support
|
| APOLLO BGS HOSPITAL,
ADICHUNCHANAGIRI ROAD,
MYSORE-570023,
KARNATAKA,
INDIA |
|
|
Primary Sponsor
|
| Name |
MOHAMMED ZAHEER PASHA |
| Address |
CRITICAL CARE DEPARTMENT
APOLLO BGS HOSPITAL
ADICHUNCHANAGIRI ROAD
MYSORE- 570023
KARNATAKA
INDIA |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MOHAMMED ZAHEER PASHA |
APOLLO BGS HOSPITAL MYSORE |
CRITICAL CARE MEDICINE DEPARTMENT
MICU
3RD FLOOR
ADICHUNCHANGIRI ROAD, KUVEMPUNAGAR, MYSORE
Mysore
KARNATAKA |
9742913961
mzp.245@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE- BIO MEDICAL RESEARCH, APOLLO BGS HOSPITAL, MYSORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
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 |
Patients who give valid informed consent.
Patients diagnosed with pneumonia.
|
|
| ExclusionCriteria |
| Details |
Patients not giving consent.
Low quality sputum sample.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the diagnostic performance of BioFire Pneumonia Panel (BFPP) in comparison with standard-of-care (SOC) culture for rapidly detecting respiratory pathogens and genetic markers among patients with pneumonia. |
AFTER THE CULTURE REPORTS COMES. USUALLY 3 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. To evaluate the performance of BFPP in detecting antimicrobial susceptibility genes compared with culture based methods & its impact on antimicrobial stewardship. |
AT THE TIME OF DISCHARGE. VARIES FROM PATIENT TO PATIENT. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/05/2026 |
| 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
|
Pneumonia remains one of the most common and
life-threatening infections encountered in the intensive care unit. Defining the
microbiological cause of lower respiratory tract infections is challenging.
Antibiotics administered for suspected pneumonia are often empirically
prescribed and might be unnecessarily broad-spectrum or not needed at all for
some patients. Contrarily in some delays in pathogen-specific, appropriate
antimicrobial therapy have reported in extremely high mortality.
The
available data show that rapid molecular diagnostics provide evidence-based
opportunities for diagnosing microbiological cause and antimicrobial
stewardship interventions . As the biofire is comparatively newer modality
of testing its efficacy, cost justification and impact on clinical outcome
needs to be further evaluated in the Indian set up. |