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Finding the Best Approach to Treat Chest Infections with Pus in Kids: Is It Better to Start with Surgery or with Medication?

Comparative Efficacy of Sequential VATS and Streptokinase Therapy versus streptokinase followed by VATS in Paediatric Empyema. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066603
Enrollment
46
Registered
2024-05-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: J869- Pyothorax without fistula

Interventions

Intervention1: 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 tho

Sponsors

Rashi
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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%.Timepoint: 6 hours 24 hours 48 hours

Secondary

MeasureTime frame
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.Timepoint: 6 months

Countries

India

Contacts

Public ContactRashi

All India Institute of Medical Sciences Patna

rashi@aiimspatna.org7044223677

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026