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Short Duration High Intensity Intrapleural Alteplase With Pulmozyme in Pleural Infection Management

Sponsor
National University of Malaysia (Other)
Overall Status
Completed
CT.gov ID
NCT04915586
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
12.1
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study was to assess the efficacy of the modified regimen short duration intrapleural 16mg alteplase (Actilyse, Boehringer Ingelheim) with 5mg DNase (Pulmozyme Hoffmann-La Roche Ltd) in patients with pleural infection.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg
 N/A

Detailed Description

The regimen 10 mg alteplase and 5 mg DNase twice daily that was used in MIST-2 trial is still an empiric choice. The rationale of using 3 doses of 16 mg alteplase dose (with supplementary 5 mg DNase) in our study was governed by the formulation of alteplase in our country (50 mg per ampoule); hence, it is best used within 24 hours following reconstitution as its biochemical stability up to 24 hours as assessed by in vitro clot lysis assays.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
The radiologists were blinded to patient identity and intervention timing
Primary Purpose:
Treatment
Official Title:
Short Duration High Intensity Intrapleural Alteplase With Pulmozyme (DNase) in Pleural Infection Management- Single Centre Experience
Actual Study Start Date :
Dec 30, 2019
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Arm

Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours Intervention Drug: Combination Alteplase and pulmozyme (DNase)

Drug: Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg
Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours
Other Names:
  • Combination Tissue Plasminogen Activator (t-PA) and Pulmozyme (DNase)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Radiographic improvement in pleural opacity on chest radiograph [Day 7]

      measured in percentage

    Secondary Outcome Measures

    1. pleural fluid volume drained [Day 7]

      measured in mls

    2. changes in inflammatory markers C-Reactive Protein (CRP ) [Day 7]

      reduction of inflammatory markers trend

    3. White cell count [Day 7]

      changes in inflammatory markers trend

    4. length of hospitalisation [upto 30 days]

      days

    5. the need of surgical referral [upto 30 days]

      if evidence of clinical deterioration post intrapleural therapy such as intrapleural haemorrhage or hypotension or less than 50% resolution of effusion on chest-xray post intrapleural therapy

    6. adverse events post therapy [Day 7]

      pain, bleeding events, hemodynamic stability

    7. mortality rate at day 30 post intervention [30 days]

      days

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • adult patient with age more than 17 year old

    • evidence of complex parapneumonic effusion or empyema; with poor pleural fluid drainage of ≤150 mL after 24 hours of insertion of chest drain

    • clinical evidence of infection such as fever and or elevated C-reactive protein (CRP) or white-cell count

    • complex pleural effusion proven by ultrasound

    • pleural fluid analysis that fulfilled at least one of the characteristics: frank pus, exudative nature (according to light's criteria), gram stain or culture positive, lactate dehydrogenase (LDH) > 1000 U/L, pH < 7.2 and/or glucose level < 3.3mmol/L

    Exclusion Criteria:

    • known allergy to pulmozyme or alteplase

    • acute stroke, active bleeding diathesis

    • major surgery in past 5 days

    • previous pneumonectomy on the infected side

    • bronchopleural fistula

    • pregnancy

    • coagulopathy (INR > 2, APTT >100, platelet count < 50,000 cells)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Kebangsaan Malaysia Medical Centre Cheras Kuala Lumpur Malaysia 56000

    Sponsors and Collaborators

    • National University of Malaysia

    Investigators

    • Principal Investigator: Mohamed Faisal Abdul Hamid, Associate Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohamed Faisal Abdul Hamid, Associate Professor, National University of Malaysia
    ClinicalTrials.gov Identifier:
    NCT04915586
    Other Study ID Numbers:
    • FF-2020-008
    • NMRR-19-2940-51404
    First Posted:
    Jun 7, 2021
    Last Update Posted:
    Jun 7, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mohamed Faisal Abdul Hamid, Associate Professor, National University of Malaysia
    Intrapleural fibrinolysis, pleural infection
    Additional relevant MeSH terms:
    Infections
    Empyema
    Tissue Plasminogen Activator
    Plasminogen

    Study Results

    No Results Posted as of Jun 7, 2021