💬In plain words
What the trial is, and whether it could suit you
A parapneumonic pleural infection is a frequently encountered and serious medical emergency with high morbidity and mortality in specific patient groups (especially in the elderly and immunocompromised). The burden of disease is high; extensive hospital stays, reduced Health-Related Quality of Life (HR-QoL) and long times to return to daily activities or to work are reported by patients and in studies. Standard care of pleural infections consists of placement of a chest tube and antibiotics. It is estimated that approximately 50% of patients with a pleural infection can be treated successfully with this strategy. When standard care fails, two main treatment modalities are available. One is intrapleural enzymatic therapy (IET), where medication is inserted through the chest tube. The other modality is minimally invasive surgery by video-assisted thoracoscopic surgery (VATS). Although both
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Age ≥ 18 years with pneumonia and suspected parapneumonic pleural infection, evidenced by (both obligatory):
* Pleural fluid which is either
* Purulent
* Gram stain or culture positive
* Acidic (pH\<7.2)
* Low in glucose (\<2 mmol/L)
AND
* Radiological suspicion of parapneumonic pleural infection (on either radiograph, ultrasound (US) or Computed Tomography-scan (CT-scan)), e.g. showing septations (US) or pleural contrast enhancement (CT)
* Fit for surgery (ie able to be ventilated on one lung during the procedure).
* Failure of standard care (consisting of a chest tube and antibiotics) as judged by the treating physician ≤ 24 h after chest tube insertion, considering: Radiology (significant residual pleural collections on imaging); Insufficient decrease of inflammatory markers (C-reactive protein (CRP) and white blood cell (WBC)); Clinical status of the patient (lack of improvement).
* Able to provide informed consent.
Exclusion Criteria:
* Patients not fit for surgery.
* Patients requiring direct surgery (e.g. dry tap). These are patients in which a non-surgical approach is considered to be not successful from the start. This decision will be made by combining the clinical status of the patient and the findings of the additional (radiological) investigations.
* Patients with a suspected or confirmed bronchopleural fistula.
* Need for more than two chest tubes at presentation.
* Any contraindication to IET (bleeding risk, allergy).
* A parapneumonic pleural infection with another cause than a pneumonia (e.g. infection after an intervention or after pulmonary/esophageal surgery, but also pneumonia related to obstruction due to lung cancer).
* Previous treatment of a parapneumonic pleural infection \<1 year ago, a history of pulmonary surgery on the same side of the parapneumonic pleural infection.
* Life expectancy \<3 months and/or suffer from a terminal illness.
* Patients who are pregnant or lactating (pregnancy status will be confirmed prior to randomisation for woman of childbearing potential).
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