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CTRI Number  CTRI/2025/08/093299 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On: 19/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Understanding pus infection around lungs in children-its pattern and how they recover 
Scientific Title of Study   Clinico-Epidemiological Bacteriological Profile and Outcome of children with Empyema Thoracis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alpana Prasad 
Designation  Vice Chairperson and Senior consultant 
Affiliation  Sir Ganga Ram Hospital, Delhi 
Address  Paediatric surgery department office, 7th floorE block, Sir Ganga Ram, Old Rajinder Nagar, Delhi

New Delhi
DELHI
110060
India 
Phone  9810645863  
Fax    
Email  alpanaprasad@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Alpana Prasad 
Designation  Vice Chairperson and Senior consultant 
Affiliation  Sir Ganga Ram Hospital, Delhi 
Address  Paediatric surgery department office, 7th floorE block, Sir Ganga Ram, Old Rajinder Nagar, Delhi

New Delhi
DELHI
110060
India 
Phone  9810645863  
Fax    
Email  alpanaprasad@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Megha Chauhan 
Designation  DrNB trainee 
Affiliation  Sir Ganga Ram Hospital, Delhi 
Address  Paediatric surgery department office, 7th floorE block, Sir Ganga Ram, Old Rajinder Nagar, Delhi

New Delhi
DELHI
110060
India 
Phone  7018820193  
Fax    
Email  Meghachauhan0000@gmail.com  
 
Source of Monetary or Material Support  
Sir Ganga Ram Hospital, Old Rajinder Nagar ,New Delhi, India, Pincode 110060 
 
Primary Sponsor  
Name  Sir Ganga Ram Hospital 
Address  Sir Ganga Ram Hospital, Rajinder Nagar New Delhi, Delhi-110060 
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 Alpana Prasad  Sir Ganga Ram Hospital, New Delhi  Paediatric surgery department office, 7th floorE block, Sir Ganga Ram, Old Rajinder Nagar, Delhi
New Delhi
DELHI 		 09810645863

alpanaprasad@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Sir Ganga Ram Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J86||Pyothorax,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  3.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children diagnosed with empyema thoracis between age 3 months to 18 years 
 
ExclusionCriteria 
Details  Case of empyema thoracis secondary to-
1) Thoracic injury
2)Bronchogenic carcinoma
3)Post surgical infections
4)Post surgical intervention

Failure to obtain consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A)-Clinico-epidemiological profile-
1)Age
2)Gender
3)Vaccination status (PCV,HiB)
4)Recent history of hospitalization with pneumonia (past one month)
5)Recent history of Antibiotic use (past 1 month)
6)Clinical features like fever,cough, chest pain, respiratory distress.

B)Bacteriological profile-
1)Pleural fluid
2)Blood culture
3)Respiratoty biofire
4)ZN stain of pleural aspirate/tissue.

 		 During hospital stay of patient
(from admission up till treatment) no post discharge follow up


 
 
Secondary Outcome  
Outcome  TimePoints 
1)Duration of ICU stay
2)Duration of hospital stay
3)Complications-
a)Empyema necessitans
b)Bronchopleural fistula
c)Non-resolving collapse
d)Infection to distant organs
e)Need for further intervention 		 During hospital stay of patient
Patient after discharge would not be followed up 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   04/09/2025 
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="4"
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 - 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

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [Meghachauhan0000@gmail.com].

  6. For how long will this data be available start date provided 01-08-2025 and end date provided 25-04-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Empyema thoracis is a collection of suppurative fluid in the pleural cavity secondary to bacterial pneumonia. It is frequently seen affecting paediatric age group, with reported incidence of 3.3 pre 100000 children. The disease can cause significant morbidity in children if adequate treatment is not given in time. Various treatment options include antibiotic alone or chest tube drainage, intrapleural fibrinolytics, video assisted thoracoscopic surgery (VATS), and open decortication. We plan to do a prospective hospital-based observational study from April 2025 to March 2029 in children between age group of 3 months to 18 years diagnosed with empyema both clinically and radiologically. We plan to determine the clinico-epidemiological and bacteriological profile of pediatric patients with empyema thoracis and to study treatment outcome of patient during their hospital stay. Relevant clinical and demographic details will be noted as per study profile. Bacteriological profile of pleural aspirate and blood culture in patients will be noted. Following outcomes will be assessed and reported in terms of duration of ICU stay, duration of hospital stay and complications during hospital stay. 
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