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CTRI Number  CTRI/2024/05/066603 [Registered on: 01/05/2024] Trial Registered Prospectively
Last Modified On: 29/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Finding the Best Approach to Treat Chest Infections with Pus in Kids: Is It Better to Start with Surgery or with Medication? 
Scientific Title of Study   Comparative Efficacy of Sequential VATS and Streptokinase Therapy versus streptokinase followed by VATS in Paediatric Empyema. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rashi 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  Dept of Pediatric Surgery 2nd Floor OPD Building AIIMS Patna

Patna
BIHAR
801505
India 
Phone  7044223677  
Fax    
Email  rashi@aiimspatna.org  
 
Details of Contact Person
Scientific Query  
Name  Rashi 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  Dept of Pediatric Surgery 2nd Floor OPD Building AIIMS Patna

Patna
BIHAR
801505
India 
Phone  7044223677  
Fax    
Email  rashi@aiimspatna.org  
 
Details of Contact Person
Public Query  
Name  Rashi 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  Dept of Pediatric Surgery 2nd Floor OPD Building AIIMS Patna

Patna
BIHAR
801505
India 
Phone  7044223677  
Fax    
Email  rashi@aiimspatna.org  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Patna, AIIMS Patna Phulwarisharif Road, Patna, Bihar 801507. 
 
Primary Sponsor  
Name  Rashi 
Address  Dept of Pediatric Surgery 2nd Floor OPD Building AIIMS Patna 
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 Rashi  All India Institute of Medical Sciences Patna  Department of Pediatric Surgery Room No-224. 2nd Floor OPD Building.
Patna
BIHAR 		 7044223677

rashi@aiimspatna.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-AIIMS-P ALL INDIA INSTITUTE OF MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: J869||Pyothorax without fistula,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Streptokinase First  Group B: This group will first receive Streptokinase injection followed by VATS. After randomization, each patient will receive an intrapleural injection of streptokinase at a dosage of 15,000 IU per kg of body weight. This will be administered via an intercostal drain tube, which will be clamped following the injection. The treatment will be administered once daily for two consecutive days. Twenty-four hours after the second injection, the patient will undergo video-assisted thoracoscopic surgery (VATS). 
Intervention  VATS First  Group A: This group will first undergo VATS and then receive Streptokinase injection 24 hours post-VATS. After randomization, patients will first undergo video-assisted thoracoscopic surgery (VATS). Twenty-four hours following the VATS procedure, they will begin a treatment regimen consisting of intrapleural injections of streptokinase. Each injection, administered at a dosage of 15,000 IU per kg of body weight, will be given through an intercostal drain tube. This tube will be clamped after each injection. The treatment will be administered once daily for two consecutive days.  
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Children aged 1 month to 15 years with a clinical diagnosis of Stage II or early-Stage III thoracic empyema.
No previous use of Streptokinase.
Pleural thickening less than 5 mm confirmed through USG and CECT Thorax.
Presence of unilateral loculated pleural effusion with septation. 
 
ExclusionCriteria 
Details  Known hypersensitivity or contraindications to Streptokinase.
Children with a medical history of congenital vascular anomalies, hypoxic-ischemic encephalopathy, arteriovenous malformation, or bronchopleural fistula.
Presence of other severe comorbidities or conditions of immunosuppression. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical resolution of symptoms such as fever and respiratory distress evidenced by the patient being afebrile for the last 24 hours and having ICD drainage of less than 15 ml in the last 24 hours.

Radiological measures involving lung expansion, assessed through imaging at 6 and 48 hours post VATS. Minimal lung expansion should be 80%. 		 6 hours 24 hours 48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Time to full resolution of empyema, measured in days post-intervention. Presence or absence of complications such as bleeding or other infections resulting from the Streptokinase injection.

Length of hospital stay post-intervention.

Any recurrence of empyema within a 6-month follow-up period. 		 6 months 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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 3 
Date of First Enrollment (India)   13/05/2024 
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="3"
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  
Background: Empyema thoracis in pediatric populations poses a significant healthcare challenge, characterized by the accumulation of infected fluid in the pleural cavity. Video-assisted thoracoscopic surgery (VATS), complemented by chest tube drainage and antibiotics, has been the standard treatment. However, some cases persist with infection and inflammation post-VATS, necessitating further intervention. Streptokinase, known for its fibrinolytic properties, offers potential as an adjunct therapy, but its efficacy post-VATS remains underexplored.
Novelty: This study introduces a novel approach to treating pediatric thoracic empyema by evaluating the sequential administration of VATS and Streptokinase against the standard sequence (Streptokinase followed by VATS). The novelty lies in investigating whether the order of these treatments impacts the effectiveness in resolving empyema, a question not previously addressed in existing literature.
Objectives: The primary objective is to compare the average number of days with drainage between the two treatment groups. Secondary objectives include assessing differences in empyema resolution rates, complication frequencies, and recurrence within a 6-month period.
Methods: A randomized controlled trial will be conducted over three years, involving 46 pediatric patients with Stage II or early-Stage III thoracic empyema. Participants will be allocated to either VATS followed by Streptokinase or the standard sequence. Primary and secondary outcomes
will be analysed using statistical tests, including survival analysis to determine median time to drainage and risk factors for delayed resolution.
Expected Outcome: The study anticipates showing a significant difference in drainage duration between the two treatment sequences, potentially offering a more effective treatment protocol for pediatric empyema. These findings could lead to revised clinical guidelines and improved patient outcomes in this challenging medical condition.
 
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