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CTRI Number  CTRI/2025/12/099402 [Registered on: 18/12/2025] Trial Registered Prospectively
Last Modified On: 18/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Using Procalcitonin Levels to Help Decide Antibiotic Treatment in Children With Lower Respiratory Tract Infections. 
Scientific Title of Study   Antibiotic stewardship initiative: A procalcitonin based approach to guide antibiotic therapy in pediatric lower respiratory tract infection. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ishita Diwedy 
Designation  DNB Resident 
Affiliation  Government Multispeciality Hospital 
Address  High Dependancy Unit(Room no 102) ,Advanced Pediatrics Centre ,Department of Pediatrics ,Government multispeciality hospital , Sector 16A

Chandigarh
CHANDIGARH
160015
India 
Phone  6203176631  
Fax    
Email  ishitadiwedy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ishita Diwedy 
Designation  DNB Resident 
Affiliation  Government Multispeciality Hospital 
Address  High Dependancy Unit(Room no 102) ,Advanced Pediatrics Centre, Department of Pediatrics ,Government multispeciality hospital , Sector 16A

Chandigarh
CHANDIGARH
160015
India 
Phone  6203176631  
Fax    
Email  ishitadiwedy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shashikiran Singh 
Designation  Medical Officer , GMSH-16 
Affiliation  Government multispeciality hospital sector16 
Address  High Dependancy Unit(Room no 102) ,Advanced Pediatrics Centre,Department of Pediatrics ,Government multispeciality hospital , sector 16

Chandigarh
CHANDIGARH
160015
India 
Phone  9814735929  
Fax    
Email  singhshashukiran72@gmail.com  
 
Source of Monetary or Material Support  
Department of pediatrics , Government Multispeciality Hospital Sector 16 Chandigarh pincode - 160015 India 
 
Primary Sponsor  
Name  Depatment of pediatrics ,Government multispeciality Hospital 
Address  Government multispeciality Hospital, Sector 16A , Chandigarh ( P.O 160015) 
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 Shashikiran Singh  Government multispeciality hospital  High Dependancy Unit(Room no 102) ,Advanced Pediatrics Centre, Department of pediatrics
Chandigarh
CHANDIGARH 		 9814735929

singhshashikiran72@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee GMSH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, (2) ICD-10 Condition: J159||Unspecified bacterial pneumonia, (3) ICD-10 Condition: J12||Viral pneumonia, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Procalcitonon based intervention to guide antibiotics therapyacute lower respiratory tract infection in pediatric population.  Use of procalcitonon values to initiate , continue , discontinue antibiotics in acute lower respiratory tract infection in pediatric population. The duration of the intervention will depend upon PCT values which will be measured at admission then at 48 hour interval. the intervention will be discontinued when the PCT value will be less than 0.5ng/dl or 80% reduction from initial value. hence the duration of intervention is dynamic and depends upon the pct values. 
Comparator Agent  Use of antibiotics as per standard treatment protocols in acute lower respiratory tract infection in pediatric population.  To initiate , continue and discontinue antibiotics as per standard treatment protocols in acute lower respiratory tract infection in pediatric population. 
 
Inclusion Criteria  
Age From  2.00 Month(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Children aged 2 months to 5 years with clinical diagnosis of lower respiratory tract infection like pneumonia , bronchitis , bronchiolitis with or without radiological confirmation and with informed consent from parents or guardians. 
 
ExclusionCriteria 
Details  The exclusion criteria included neonates, children with known immunodeficiency conditions such as HIV infection, malignancy, post-transplant status, or primary immunodeficiency disorders. Children with chronic lung diseases including cystic fibrosis and bronchiectasis were also excluded. Patients presenting with severe sepsis, empyema, pleural effusion, or those requiring ICU admission at presentation were not included. Additionally, children who had received antibiotics within the previous seven days or whose parents or guardians refused consent or withdrew consent were excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To decide on the duration of antibiotic therapy based on Procalcitonin values.  On the day of completion of antibiotic course based Procalcitonin values which are to be measured at admission and subsequently at 48 hour interval until below the cut off value. 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the rate of antibiotic initiation based on Procalcitonin based therapy.  At the time of initial clinical assessment or hospital admission. 
To compare the length of hospital stay between the Procalcitonin guided group and the standard care group.  At hospital discharge 
To evaluate the incidence of antibiotic associated adverse effects in both groups.  Throughout hospitalization and at discharge or within seven days of discharge. 
To assess clinical outcomes including treatment failure, relapse, ICU transfer, and mortality.  During hospital stay and up to 7 days post discharge. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   11/01/2026 
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 Applicable 
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  

This randomized controlled trial investigates the effectiveness of a procalcitonin guided approach to antibiotic therapy in children aged two months to five years admitted with lower respiratory tract infections. These infections are a major cause of hospitalization and antibiotic use in pediatric populations. Although many of these illnesses are viral, antibiotics are frequently prescribed due to the difficulty in clinically distinguishing viral from bacterial infections. This leads to unnecessary antibiotic exposure, which contributes to the growing problem of antimicrobial resistance, longer hospital stays, increased healthcare costs, and avoidable drug related adverse effects.

Procalcitonin is a biomarker that increases in bacterial infections and remains low in viral illnesses, making it a valuable tool to guide antibiotic decision making. The purpose of the study is to assess whether using procalcitonin levels to initiate and discontinue antibiotics can optimize therapy without compromising patient safety. Participants in the intervention arm receive antibiotic decisions based on predefined procalcitonin thresholds, while the control group follows standard clinical judgment.

The primary objective is to evaluate the duration of antibiotic use based on procalcitonin levels. Secondary objectives include assessing the rate of antibiotic initiation, hospital stay length, antibiotic associated adverse events, and clinical outcomes such as treatment failure, relapse, ICU transfer, and mortality. The central hypothesis is that procalcitonin guided therapy will significantly reduce unnecessary antibiotic use, minimize hospital stay, and maintain comparable or better clinical outcomes compared to standard care. Ethical approval, informed consent, and adherence to national and international guidelines ensure that the study upholds patient safety and research integrity.

This trial aims to provide strong clinical evidence supporting biomarker based antibiotic stewardship in pediatric lower respiratory tract infections, potentially informing future treatment protocols and helping address the global threat of antimicrobial resistance.

 
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