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Role of Medical Thoracoscopy in Pleural Infection (PROMPT Trial)

NCT07550530 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-04-24

No results posted yet for this study

Summary

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

Conditions

  • Pleural Infection
  • Pleural Infections
  • Pleural Infections and Inflammations

Interventions

PROCEDURE

medical thoracoscopy

This 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.

PROCEDURE

Standard of Care

The 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.

Sponsors & Collaborators

  • Università Politecnica delle Marche

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-01
Primary Completion
2028-10-31
Completion
2029-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07550530 on ClinicalTrials.gov