Chest ultrasonographic evaluation after intrapleural Alteplase versus Streptokinase injection in Children with Empyema - Trial PACTR202306656398595
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Study Focus
Sponsor & Location
Assiut University Children Hospital.
Principal investigator
Timeline & Enrollment
Phase 3
Apr 30, 2023
Apr 30, 2025
Summary
Empyema is the state in which purulent fluid is present in the pleural space. If pleural effusion is purulent, a diagnosis of empyema is given even if a microbial test is not positive (1).CPPE (complicated parapneumonic effusion) was defined as nonpurulent effusions in a patient with clinical evidence of infection such as fever and/or elevated blood leukocyte count and/or elevated CRP (C-reactive protein), with pleural fluid pH<7.2 (measured by blood-gas analyzer), pleural fluid glucose,60 mg/dl, or pleural-fluid lactate dehydrogenase (LDH).1,000 IU/L (2).Parapneumonic effusion or pleural empyema (PPE/PE) is a frequent complication of community-acquired pneumonia (CAP) in children. Different management approach exist for this condition(3).Parapneumonic pleural effusions may occur in 3657% of patients with pneumonia and about 1520% of this accumulated fluid becomes infected resulting in empyema (4).Drainage of the collection in early stage by intercostal tube with administration of proper antibiotics according to the culture and sensitivity is considered the cornerstone of treatment(5).Clinical guidelines recommend that empyema is to be treated with chest tube insertion and intrapleural fibrinolytics (6).Variety of fibrinolytic agents such as streptokinase, alteplase and urokinase had been administered selectively and safely in the management of pleural effusion and empyema (7).Intrapleural fibrinolytic therapy was often used in pediatric empyema, despite limitations with current evidence (8). The aim of this study is to compare the benefit of intrapleural injection of tissue plasminogen activator versus streptokinase in children with CPPE or empyema in length of stay in hospital following chest tube and need for additional surgical pleural drainage procedures.1. Kanai E, Matsutani N. Management of empyema: A comprehensive review. Curr Chall Thorac Surg. 2020;2:38.2. Kheir F, Thakore S, Mehta H, Jantz M, Parikh M, Chee A, et al. Intrapleural fibrinolytic
ICD-10 Classifications
Data Source
Pan Africa Clinical Trials Registry
PACTR202306656398595
Non-Device Trial

