NCT05766124 Trial of Reduced Alteplase Dose for Parapneumonic Effusion (TRAPPE)
| NCT ID | NCT05766124 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Chinese University of Hong Kong |
| Condition | Pleural Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2024-11-01 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Objectives: A pilot study to assess the feasibility of a randomization trial protocol comparing low (2.5mg) and standard (10mg) doses of intrapleural tissue plasminogen activator (tPA) with deoxyribonucleases (DNase) in unresolved pleural infection. Hypothesis: The proposed randomized protocol comparing low dose and standard doses of intrapleural tPA (with DNase) therapy will be feasible and acceptable. Design and subjects: A single-center, two-arm, double-blinded, randomized controlled feasibility study which includes subjects with unresolved pleural infection eligible for intrapleural tPA/DNase injection, with follow-ups till 3 months after hospital discharge. Interventions: Recruited subjects will be randomized in 1:1 ratio to receive a maximum of 6 doses of intrapleural tPA (with DNase) starting at either 2.5mg or 10mg. A clinical decision is allowed at or after the third dose of tPA to continue with the assigned regimen (blinded) or convert to open-label use of 10mg doses of tPA to complete the course based on the clinical response. Main outcome measures: The main outcome is the feasibility of the trial protocol, based on the percentage of eligible patients enrolled, retained to discharge, and completing 3 months of follow-up. Other important outcomes include survival at 3 months follow-up and without the need for surgical intervention, the need for additional pleural interventions, the number of decisions to convert to open-labelled use of 10mg intrapleural tPA, clinical and radiographic response after the treatment course, safety profiles, especially bleeding complications and the number and reason for protocol violation. Data analysis and expected results: Feasibility outcomes will be reported as descriptive data. Comparison of outcomes between the two treatment groups will be analyzed on an intention-to-treat basis. Safety outcomes will be reported descriptively for each group. The reported estimates of recruitment rates, adherence, follow-up completeness, and variability and event rates for key clinical and bleeding outcomes will be used, to inform the design and sample size considerations future studies incorporating the current study design
Eligibility Criteria
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.
Contact & Investigator
David SC Hui, MD
STUDY DIRECTOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT05766124 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pleural Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05766124 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05766124 currently recruiting?
Yes, NCT05766124 is actively recruiting participants. Contact the research team at chankapang@cuhk.edu.hk for enrollment information.
Where is the NCT05766124 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong, Hong Kong, Hong Kong.
Who is sponsoring the NCT05766124 clinical trial?
NCT05766124 is sponsored by Chinese University of Hong Kong. The principal investigator is David SC Hui, MD at Chinese University of Hong Kong. The trial plans to enroll 30 participants.