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Chest ultrasonographic evaluation after intrapleural Alteplase versus Streptokinase injection in Children with Empyema - Trial PACTR202306656398595

Access comprehensive clinical trial information for PACTR202306656398595 through Pure Global AI's free database. This Phase 3 trial is sponsored by Assiut University Children Hospital. and is currently Recruitment Completed. The study focuses on Respiratory; Paediatrics.

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PACTR202306656398595
Phase 3
Recruitment Completed
drug
Trial Details
Pan Africa Clinical Trials Registry โ€ข PACTR202306656398595
Pure Global
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Chest ultrasonographic evaluation after intrapleural Alteplase versus Streptokinase injection in Children with Empyema

Study Focus

Respiratory; Paediatrics

drug

Sponsor & Location

Assiut University Children Hospital.

Principal investigator

Egypt

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

Other postprocedural respiratory disorders
Respiratory disorder, unspecified
Other specified respiratory disorders
Diseases of the respiratory system
Other respiratory disorders

Data Source

Pan Africa Clinical Trials Registry

PACTR202306656398595

Non-Device Trial