Role of Medical Thoracoscopy in Pleural Infection (PROMPT Trial)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversità Politecnica delle Marche
About this trial
The PROMPT study is testing whether an early keyhole procedure called Medical Thoracoscopy, which lets doctors look inside the chest and remove infected fluid, works better than current standard treatment (medicines to break up thick fluid) for people with pleural infection. About 170 patients in several hospitals will be randomly assigned to one of the two treatments, and researchers will see which approach results in fewer additional procedures-such as another drain or surgery-within 30 days, as well as how quickly people recover and whether they experience any complications. Everyone in the study receives high-quality care, and the results will help doctors better understand which treatment gives patients the best chance of recovering quickly and safely
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥ 18 years
Clinical and radiological diagnosis of pleural infection (purulent, culture-positive, or pH < 7.2)
Need of pleural drainage
Able and willing to give informed consent
Disqualifiers
Chest drain in situ >24h before randomisation
Post-traumatic pleural effusion
Known allergy to fibrinolytic agents or contraindication to thoracoscopy
Pregnancy or breastfeeding
Trial design
Design model
Parallel
Treatments tested in this trial
medical thoracoscopy
Procedure/SurgeryThis is a minimally invasive procedure performed to directly treat pleural infection by entering the pleural cavity through a small incision in the chest wall. It is carried out under local anaesthesia combined with conscious sedation. This means the patient remains comfortable and relaxed but does not require general anaesthesia. A trained chest physician or interventional pulmonologist performs the procedure, usually inside a dedicated interventional pulmonology or endoscopy suite. A small cut (usually 1-2 cm) is made on the side of the chest. Through this opening, the doctor inserts a rigid or semi-rigid thoracoscope-a thin tube equipped with a camera and light source. This allows direct visualisation of the pleural space, enabling the doctor to identify pockets of infected fluid, adhesions, or fibrinous strands that might prevent effective drainage.
Standard of Care
Procedure/SurgeryThe Standard of Care (SoC) for pleural infection in this trial consists of image-guided chest drainage and systemic antibiotics + fibinolytics. An image-guided chest drain of at least 12 French is inserted using ultrasound or CT to remove infected fluid from the pleural space. Antibiotics are administered according to current guidelines. Drain management and supportive care follow institutional standards, and additional procedures are permitted only if predefined criteria for treatment failure are met. To improve drainage, participants are given intrapleural fibrinolytics according to the MIST-2 protocol: tPA 10 mg plus DNase 5 mg twice daily for 3 days. If tPA/DNase is not available, urokinase may be used instead following local routine practice (typically 100,000 IU in a single daily dose for up to two days). Drain management and supportive care follow institutional standards, and additional procedures are permitted only if predefined criteria for treatment failure are met.
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Medical Thoracoscopy (MT)Experimental treatment 1 intervention
Group B: Standard of Care (SoC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Further pleural interventions
Need for any further pleural procedure within 30 days (repeat thoracentesis or drainage, additional fibrinolytic course, or surgery).
Time frame
from the randomization up to 30 daysSecondary outcomes
1
Hospital length of stay
days from admission up to 90 days (end of the study)
Time frame
from the randomization up to the end of study at 90 days2
Surgical referral
Need for surgical thoracoscopy (VATS) up to 90 days (end of the study)
Time frame
from the randomization to the end of study at 90 days3
Mortality
30- and 90-day mortality up to 90 days (end of the study)
Time frame
From the randomization at 30 and 90 days4
Patient-reported pain
Pain reported as per VAS (visual analogue scale) from 0 to 10 up to 90 days (end of the study)
Time frame
From the intervention up to 90 days (end of the study)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: