Finding the Best Approach to Treat Chest Infections with Pus in Kids: Is It Better to Start with Surgery or with Medication?
Phase 3
- Conditions
- Health Condition 1: O- Medical and SurgicalHealth Condition 2: J869- Pyothorax without fistula
- Registration Number
- CTRI/2024/05/066603
- Lead Sponsor
- Rashi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
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.
Exclusion Criteria
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br> <br/ ><br>Radiological measures involving lung expansion, assessed through imaging at 6 and 48 hours post VATS. Minimal lung expansion should be 80%.Timepoint: 6 hours 24 hours 48 hours
- Secondary Outcome Measures
Name Time Method 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. <br/ ><br> <br/ ><br>Length of hospital stay post-intervention. <br/ ><br> <br/ ><br>Any recurrence of empyema within a 6-month follow-up period.Timepoint: 6 months