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NOT YET RECRUITING
NCT07858721
NA

Study of Medical Thoracoscopy in Early Pleural Infection

Sponsor: Alexandria University

View on ClinicalTrials.gov

Summary

Pleural infection (which is the infection in the space around the lungs called the pleura) is a severe infection that is difficult to treat and can lead substantial disability or even death. This infection is associated with fluid build up in the pleura and draining this fluid is crucial in treating the infection. The typical method for draining this fluid is inserting a tube in the chest cavity. However, this is not successful in more than one third of patients and additional treatments including surgery are required. These additional treatments are expensive and hence not available in a lot of settings. In addition, patients with this type of infection are often not fit to undergo surgery. There are studies to suggest that a minor surgical procedure, called medical thoracoscopy, that is carried out by chest doctors and does not require general anaesthesia can help with draining the fluid in the pleura when there is infection. In order to ascertain this benefit, a study is needed to compare the effect of using medical thoracoscopy to not using medical thoracoscopy in treating pleural infection. The choice of patients needs to be in random to ensure the effects are true. The investigators aim in this study to conduct a randomized study in patients with pleural infection where half the patients will receive the standard chest tube treatment and the other half will have medical thoracoscopy in addition to the standard tube. The study will monitor the treatment outcomes for each group to find out whether the newer treatment improves these outcomes.

Official title: Study of Medical Thoracoscopy in Early Pleural Infection (STEP) - a Multicentre Randomised Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2026-11-01

Completion Date

2029-04-30

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

PROCEDURE

Medical thoracoscopy plus standard of care

Local anaesthetic thoracoscopy done in spontaneously breathing patients with pleural infection with the aim of optimising drainage of the infected fluid. This will be performed plus standard of care including antibiotics, venous thromboprophylaxis and intrapleural therapy.

DRUG

Standard of Care (Investigator Choice)

This will include antibiotics, venous thromboprophylaxis and intrapleural therapy.