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Study of Medical Thoracoscopy in Early Pleural Infection

ConditionPleural Infection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexandria University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (>18 years old)

Willing to provide informed consent

the presence of pus in the pleural space;

positive pleural fluid gram stain or culture; or

Disqualifiers

Inability to undergo medical thoracoscopy within 72 hours of diagnosis confirmation

Suspected or proven tuberculous aetiology for the pleural effusion

Absolute contraindication for medical thoracoscopy per British Thoracic guidelines[11] (uncorrectable bleeding diathesis, significant pulmonary hypertension, cardiovascular instability, uncorrectable hypoxia, ongoing hypercapnia, cutaneous infection, metastasis or rib fracture around port

insertion site)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Medical thoracoscopy plus standard of care

    Procedure/Surgery

    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.

  • Standard of Care (Investigator Choice)

    Drug

    This will include antibiotics, venous thromboprophylaxis and intrapleural therapy.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Medical thoracoscopyExperimental treatment 1 intervention
Group B: Standard of care armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Length of hospital stay

Duration of initial hospital stay

Time frame
From the date of randomization to the date of discharge from hospital or the date of death for participants whichever happens first assessed up to 12 months

Secondary outcomes

1

Proportion of patients who need further ipsilateral interventions to control pleural infection within 30 days from randomisation

Additional drainage interventions include chest tube, thoracentesis or surgical evacuation

Time frame
Duration of recording of the outcome will be from randomisation to 30 days after that day

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandria University

Lead sponsor

Assiut University

Collaborator

Mansoura University

Collaborator

Ain Shams University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: