Role of Medical Thoracoscopy in Pleural Infection (PROMPT Trial)

NCT07550530 | Not Yet Recruiting DMC

• 1 other identifier: PROMPT2026
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Pleural infection; Medical Thoracoscopy; Trial

Outcome Measures

Primary Outcomes (1)

• Further pleural interventions

  Need for any further pleural procedure within 30 days (repeat thoracentesis or drainage, additional fibrinolytic course, or surgery).

  from the randomization up to 30 days

Secondary Outcomes (5)

• Hospital length of stay

  from the randomization up to the end of study at 90 days

• Surgical referral

  from the randomization to the end of study at 90 days

• Mortality

  From the randomization at 30 and 90 days

• Patient-reported pain

  From the intervention up to 90 days (end of the study)

• Procedure-related adverse events

  From the day of intervention up to 90 days (end of the study)

Study Arms (2)

Medical Thoracoscopy (MT)

EXPERIMENTAL

* Performed under local anaesthesia and conscious sedation (anaesthesiologic assistance). * Procedures include evacuation of infected fluid, breakdown of adhesions, and partial decortication if required. * A 20 F or larger drain is inserted post-procedure and connected to an underwater seal. * Standard antibiotic therapy as per guidelines.

Procedure: medical thoracoscopy

Standard of Care (SoC)

ACTIVE COMPARATOR

• Intrapleural fibrinolytic therapy: tissue plasminogen activator (tPA) 10 mg + DNase 5 mg twice daily for 3 days (per MIST-2 protocol(2)), when available, otherwise Urokinase as per routine clinical practice (i.e., 100.000UI in single administration/two days).

Procedure: Standard of Care

Interventions

medical thoracoscopy PROCEDURE

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.

Medical Thoracoscopy (MT)

Standard of Care PROCEDURE

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.

Also known as: Antibiotics + fibrinolytics

Standard of Care (SoC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Chest drain in situ \>24h before randomisation
• Post-traumatic pleural effusion
• Known allergy to fibrinolytic agents or contraindication to thoracoscopy
• Pregnancy or breastfeeding
• Life expectancy \< 3 months from another illness
• Previous lung surgery (pneumonectomy) in the same side of pleural infection
• Previous pleurodesis in the same side of pleural infection
• Any contraindication to Medical thoracoscopy

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Related Publications (5)

• Wang K, Yang L, Tian P, Tan F, Liu D, Li W. Medical thoracoscopy combined with intrapleural injection of urokinase for treatment of pleural infection-a multicenter, prospective, randomized controlled study: study protocol. Respir Res. 2025;26(1):21

  RESULT

• Roberts ME RN, Maskell NA, Bibby AC, Blyth KG, Corcoran JP, Edey A, Evison M, de Fonseka D, Hallifax R, Harden S, Lawrie I, Lim E, McCracken D, Mercer R, Mishra EK, Nicholson AG, Noorzad F, Opstad KS, Parsonage M, Stanton AE, Walker S. British Thoracic Society Guideline for pleural disease. Thorax. 2023;78:1-42.

  RESULT

• Kheir F, Thakore S, Mehta H, Jantz M, Parikh M, Chee A, et al. Intrapleural Fibrinolytic Therapy versus Early Medical Thoracoscopy for Treatment of Pleural Infection. Randomized Controlled Clinical Trial. Ann Am Thorac Soc. 2020;17(8):958-64.

  RESULT

• Najib M Rahman NAM, Alex West, Richard Teoh, Anthony Arnold, Carolyn Mackinlay, Daniel Peckham, Chris W H Davies, Nabeel Ali, William Kinnear, Andrew Bentley, Brennan C Kahan, John M Wrightson, Helen E Davies, Clare E Hooper, Y C Gary Lee, Emma L Hedley, Nicky Crosthwaite, Louise Choo, Emma J Helm, Fergus V Gleeson, Andrew J Nunn, Robert J O Davies. Intrapleural use of tissue plasminogen activator and DNase in pleural infection. N Engl J Med. 2011;365(6):518-26.

  RESULT

• Gonnelli F, Bonifazi, M., Iommi, M. et al. . Italian Multicentre study on the management of pLeural infection and Empyema: IMPLE study. Respiratory Research. 2025(26):322.

  RESULT

MeSH Terms

Conditions

Inflammation

Interventions

Standard of Care; Anti-Bacterial Agents; Thrombolytic Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Drug Therapy; Therapeutics

Central Study Contacts

Federico Mei, MD

CONTACT

+0715965538; f.mei@staff.univpm.it

Francesca Gonnelli, MD

CONTACT

+393408579087; francesca.gonnelli@pm.univpm.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04