Could a lower dose of Clot-Buster be safer for lung infections?

NCT ID NCT05766124

Symptom relief Sponsor: Chinese University of Hong Kong Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a lower dose (2.5 mg) of a clot-busting drug called tPA works as well as the standard dose (10 mg) for treating pleural infections, which cause fluid buildup around the lungs. The drug is given through a chest tube along with another enzyme to help drain the infection. The goal is to see if the lower dose reduces bleeding risk while still being effective. The study involves 30 adults with unresolved pleural infections and will track their recovery for 3 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: tissue plasminogen activator (tPA, also known as Alteplase) with deoxyribonucleases (DNase)
What this could lead to: If successful, this could point toward a safer, equally effective dose of tPA for treating pleural infections, reducing bleeding complications.
What could go wrong: This is a small pilot study with only 30 participants, so results may not apply broadly. The lower dose might be less effective, and bleeding risks remain.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Clinical features suggesting uncontrolled pleural infection with incomplete drainage of pleural effusion, at least 1 day after insertion of pleural drain (French size 12 or above) and administration of antibiotics. * Intend to administer intrapleural fibrinolytic * Written informed consent obtained Exclusion Criteria: * Previously received intrapleural tPA to the ipsilateral pleural space for the current episode of pleural infection. * Known sensitivity to tPA or DNase. * A coincidental stroke, major haemorrhage or major trauma. * Frank bleeding or evidence of puncture to the intercostal artery during chest drain insertion. * Ongoing frank bleeding from the ipsilateral pleural space. * Has had puncture of a non-compressible vessel in the previous 14 days. * Has had major surgery in the previous 14 days. * Has had unprovoked gastrointestinal bleeding or intracranial haemorrhage in the last 3 months. * Active use of anticoagulation (except prophylaxis for deep vein thrombosis) or dual-antiplatelet agents. * Active use of any systemic fibrinolytic therapy or any airway DNase therapy. * On long-term macrolide antibiotics (as they may interact with DNase). * Uncorrectable bleeding diathesis or baseline INR \> 1.5. * Has had a previous pneumonectomy (either on the same or contralateral side). * Presence of active bronchopleural fistula. * Age less than 18 years old. * Patients who are pregnant or lactating (females of childbearing potential must have a negative pregnancy test before randomisation). * Expected survival less than three months from a different pathology to this empyema (e.g. metastatic lung carcinoma). * Use of agents under research or not registered in the 30 days prior to the study. * Inability to give informed consent.

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Conditions

The condition(s) this trial relates to.

pleural empyema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pleural infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could a lower dose of Clot-Buster be safer for lung infections?

What the study statuses mean