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CTRI Number  CTRI/2025/12/098381 [Registered on: 03/12/2025] Trial Registered Prospectively
Last Modified On: 30/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic
Process of Care Changes 
Study Design  Other 
Public Title of Study   Diagnostic algorithm using nasal swab for respiratory organisms and blood marker for infection to reduce antibiotic usage in children with pneumonia 
Scientific Title of Study   Multiplex respiratory PCR and serum procalcitonin based diagnostic algorithm to reduce antibiotic usage in critically ill children admitted with pneumonia 
Trial Acronym  PCR-PCT study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Namita Ravikumar 
Designation  Assistant Professor 
Affiliation  Ramaiah Medical College 
Address  PICU, Department of Pediatrics, Ramaiah Medical College, MSR Nagar, Mathikere, Bangalore
PICU, Department of Pediatrics, Ramaiah Medical College, MSR Nagar, Mathikere, Bangalore
Bangalore
KARNATAKA
560054
India 
Phone  8826582654  
Fax    
Email  namitu.ravi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Namita Ravikumar 
Designation  Assistant Professor 
Affiliation  Ramaiah Medical College 
Address  PICU, Department of Pediatrics, Ramaiah Medical College, MSR Nagar, Mathikere, Bangalore
PICU, Department of Pediatrics, Ramaiah Medical College, MSR Nagar, Mathikere, Bangalore

KARNATAKA
560054
India 
Phone  8826582654  
Fax    
Email  namitu.ravi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Namita Ravikumar 
Designation  Assistant Professor 
Affiliation  Ramaiah Medical College 
Address  PICU, Department of Pediatrics, Ramaiah Medical College, MSR Nagar, Mathikere, Bangalore
PICU, Department of Pediatrics, Ramaiah Medical College, MSR Nagar, Mathikere, Bangalore

KARNATAKA
560054
India 
Phone  8826582654  
Fax    
Email  namitu.ravi@gmail.com  
 
Source of Monetary or Material Support  
Ramaiah University of Applied Sciences seed grant 
 
Primary Sponsor  
Name  RUAS seed grant 
Address  Ramaiah University of Applied Sciences, MSR Nagar, Mathikere, Bangalore 560054 
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 = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Namita Ravikumar  PICU, Ramaiah Medical College Hospital  PICU, 2nd floor, Ramaiah Medical College Hospital, MSR Nagar, Mathikere, Bangalore 560054
Bangalore
KARNATAKA 		 8826582654

namitu.ravi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MS Ramaiah Medical College and Hospitals  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  Diagnostic algorithm including Respiratory multiplex PCR and serum procalcitonin  Respiratory multiplex PCR by nasopharyngeal swab and serum procalcitonin done and as per report antibiotics are discontinued or changed. 
Comparator Agent  Routine investigations as per unit protocol  As per clinical discretion 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Diagnosis of pneumonia or lower respiratory tract infection
2. Requiring oxygen or higher respiratory support
3. Started antibiotic at admission 
 
ExclusionCriteria 
Details  1. Children who were treated with oral or intravenous antibiotics for more than 2 days
prior to admission
2. Lobar consolidation or empyema
3. Acute exacerbation of asthma
4. Co-morbid illness like severe acute malnutrition
5. Known immunodeficiency status like HIV, primary immunodeficiency, long term steroid use
6. Chronic respiratory diseases like cystic fibrosis, bronchiectasis
7. Chest wall or spine deformities
8. Congenital heart diseases
9. Fluid refractory shock 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the reduction of antibiotic usage after introduction of the algorithm  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Number of antibiotic days before & after the algorithm
2.To assess the proportion of children requiring re-start of antibiotics after stopping or upgradation to second line antibiotics 		 1. 7 days
2. 14 days 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
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)   11/12/2025 
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)   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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [namitu.ravi@gmail.com].

  6. For how long will this data be available start date provided 12-03-2027 and end date provided 12-03-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Children admitted to PICU with a diagnosis of pneumonia or lower respiratory tract infection requiring oxygen or higher respiratory support and meet and the inclusion and exclusion criteria will be included after informed consent. Demographic data, clinical features and treatment received collected. Nasopharyngeal swab for respiratory using Multiplex PCR ans serum procalcitonin will be sent. Antibiotics will be stopped if no bacteria is detected and PCT is negative. Child will be monitored clinical and using Point of care ultrasound for any worsening symptoms. The control group will include historic cohort of previous year managed as per existing protocol. The change in antibiotics in historic cohort based on clinical decision, chest radiograph and inflammatory markers like CRP and total leukocyte counts will be compared with study group where antibiotic decisions are based on respiratory PCR and PCT reports. 
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