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A PILOT RCT TO COMPARE 3 VS 6 DOSES OF INTRAPLEURAL STREPTOKINASE IN PEDIATRIC EMPYEMA

COMPARISON OF 6 DOSES OF INTRAPLEURAL FIBRINOLYTIC THERAPY VS CONVENTIONAL 3 DOSES IN CHILDREN WITH EMPYEMA- A PILOT RANDOMISED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038421
Enrollment
20
Registered
2021-12-03
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: J90- Pleural effusion, not elsewhere classified

Interventions

Intervention1: Intrapleural Streptokinase: 6 doses of intrapleural Streptokinase 15000 Units/kg administered twice daily for 3 days via the Intercostal drainage tube
total duration of therapy- 3 days Control Intervention1: Intrapleural Streptokinase: 3 doses of intrapleural streptokinase- 15000 U/kg, administered once daily for 3 days via Intercostal drainage tube
total duration of therapy-3 days

Sponsors

Post Graduate Insititue of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 month-18 years age

Exclusion criteria

Exclusion criteria: Proven tuberculosis Chronic/post operative empyema/BPF Contraindications to fibrinolytic therapy

Design outcomes

Primary

MeasureTime frame
Treatment failure- persistence of fever/respiratory distress/chest findings with persistent effusionTimepoint: Day 4 of trial- after 3 or 6 doses of streptokinase are given—

Secondary

MeasureTime frame
Total volume of intrapleural fluid drained on day 4 Duration of hospitalisation after intrapleural therapy Need for surgical intervention Duration of fever and RD after intrapleural therapy Volume of fluid drained on each dayTimepoint: Day 4 of trial- after 3 or 6 doses of streptokinase are given—

Countries

India

Contacts

Public ContactDr Joseph L Mathew

Professor (Pediatric Pulmonology)

dr.joseph.l.mathew@gmail.com9417800204

Outcome results

None listed

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