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CTRI Number  CTRI/2025/11/097393 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 13/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare the effectiveness of intrapleural streptokinase with conventional treatment in children with empyema. 
Scientific Title of Study   Intrapleural streptokinase adjunct to conventional treatment vs conventional treatment in paediatric empyema-An open labelled randomized control trial. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shubham Rastogi  
Designation  Post graduate resident  
Affiliation  Lady hardinge medical college  
Address  Department of paediatrics, Lady hardinge medical college, Shaheed bhagat singh marg,DIZ Area ,Connaught place New Delhi 110001

Central
DELHI
110001
India 
Phone  8700996292  
Fax    
Email  shubhamrastogi70157@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Srikanta Basu 
Designation  Director Professor  
Affiliation  Lady hardinge medical college  
Address  Kalawati saran childrens hospital, Bangla sahib road . Central Delhi . 110001 India

Central
DELHI
110001
India 
Phone  9818291595  
Fax    
Email  srikantabasu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Srikanta Basu 
Designation  Director Professor  
Affiliation  Lady hardinge medical college  
Address  Kalawati saran childrens hospital, Bangla sahib road . Central Delhi . 110001 India

Central
DELHI
110001
India 
Phone  9818291595  
Fax    
Email  srikantabasu@gmail.com  
 
Source of Monetary or Material Support  
Kalawati saran children hospital, Lady hardinge medical college, New Delhi 110001 
 
Primary Sponsor  
Name  Shubham Rastogi  
Address  N-48 camp no 3 , Nangloi Jj colony ,West Delhi 110041 
Type of Sponsor  Other [Self] 
 
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 Shubham Rastogi   KALAWATI SARAN CHILDREN HOSPITAL  Department of paediatrics, Lady hardinge medical college Bangla Sahib Road , DIZ Area ,Connaught place
Central
DELHI 		 8700996292

shubhamrastogi70157@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE LADY HARDINGE MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J869||Pyothorax without fistula,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional treatment ( without intrapleural streptokinase)  Conventional treatment with appropriate antibiotics, chest tube drainage and supportive care as per hospital protocol.  
Intervention  Intrapleural Streptokinase   Intrapleural streptokinase administered as adjunct to conventional management . Dose - 15000 IU /kg diluted in 50 ml normal saline for 3 days 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Patients with definitive diagnosis of empyema with visible puson diagnostic pleural tap and/or septations /loculations on ultrasound of chest.  
 
ExclusionCriteria 
Details  a. Any history of coagulopathy
b. Confirmed case of pneumothorax or bronchopleural fistula
c. Any history of head trauma in preceeding 2 weeks .
d. Any history of recent major surgery .  
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in pleural fluid volume and improvement in clinical condition (resolution of fever , respiratory distress , and radiological clearance on chest x ray ).   Day 7 and at completion of hospital stay.  
 
Secondary Outcome  
Outcome  TimePoints 
Duration of hospital stay .   4 weeks  
Duration of chest tube drainage   3 weeks.  
Requirement of surgical intervention ( decortication )  4 weeks.  
Adverse effects or complications related to streptokinase   4 weeks  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 4 
Date of First Enrollment (India)   25/11/2025 
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 - NO
Brief Summary   This randomized open label controlled trial aims to evaluate the efficacy and safety of intrapleural streptokinase as an adjunct to conventional management in children with empyema . Participants aged 2 - 18 years with confirmed diagnosis of empyema will be randomized into two groups : one receiving conventional treatment alone while the other receiving intrapleural streptokinase in addition to conventional treatment . The primary outcome will be improved in clinical condition and radiological resolution , while secondary outcomes will include duration of hospital stay , need for surgical intervention and adverse effects . The study will be conducted in department of paediatrics at  kalawati saran children’s hospital.  
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