Back to resultsShort Duration High Intensity Intrapleural Alteplase With Pulmozyme in Pleural Infection Management
Primary Purpose
Loculated Empyema
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg
Sponsored by
About this trial
This is an interventional treatment trial for Loculated Empyema focused on measuring Intrapleural fibrinolysis, pleural infection
Eligibility Criteria
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)
Sites / Locations
- University Kebangsaan Malaysia Medical Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours Intervention Drug: Combination Alteplase and pulmozyme (DNase)
Outcomes
Primary Outcome Measures
Radiographic improvement in pleural opacity on chest radiograph
measured in percentage
Secondary Outcome Measures
pleural fluid volume drained
measured in mls
changes in inflammatory markers C-Reactive Protein (CRP )
reduction of inflammatory markers trend
White cell count
changes in inflammatory markers trend
length of hospitalisation
days
the need of surgical referral
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
adverse events post therapy
pain, bleeding events, hemodynamic stability
mortality rate at day 30 post intervention
days
Full Information
NCT ID
NCT04915586
First Posted
February 21, 2021
Last Updated
June 4, 2021
Sponsor
National University of Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT04915586
Brief Title
Short Duration High Intensity Intrapleural Alteplase With Pulmozyme in Pleural Infection Management
Official Title
Short Duration High Intensity Intrapleural Alteplase With Pulmozyme (DNase) in Pleural Infection Management- Single Centre Experience
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 30, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Malaysia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Loculated Empyema
Keywords
Intrapleural fibrinolysis, pleural infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
The radiologists were blinded to patient identity and intervention timing
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours
Intervention Drug: Combination Alteplase and pulmozyme (DNase)
Intervention Type
Drug
Intervention Name(s)
Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg
Other Intervention Name(s)
Combination Tissue Plasminogen Activator (t-PA) and Pulmozyme (DNase)
Intervention Description
Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours
Primary Outcome Measure Information:
Title
Radiographic improvement in pleural opacity on chest radiograph
Description
measured in percentage
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
pleural fluid volume drained
Description
measured in mls
Time Frame
Day 7
Title
changes in inflammatory markers C-Reactive Protein (CRP )
Description
reduction of inflammatory markers trend
Time Frame
Day 7
Title
White cell count
Description
changes in inflammatory markers trend
Time Frame
Day 7
Title
length of hospitalisation
Description
days
Time Frame
upto 30 days
Title
the need of surgical referral
Description
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
Time Frame
upto 30 days
Title
adverse events post therapy
Description
pain, bleeding events, hemodynamic stability
Time Frame
Day 7
Title
mortality rate at day 30 post intervention
Description
days
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Faisal Abdul Hamid
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Kebangsaan Malaysia Medical Centre
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
Citations:
PubMed Identifier
35581627
Citation
Cheong XK, Ban AY, Ng BH, Nik Abeed NN, Nik Ismail NA, Nik Fuad NF, Syed Zakaria SZ, Ghan SL, Abdul Hamid MF. Modified regimen intrapleural alteplase with pulmozyme in pleural infection management: a tertiary teaching hospital experience. BMC Pulm Med. 2022 May 17;22(1):199. doi: 10.1186/s12890-022-01995-z. Erratum In: BMC Pulm Med. 2022 Nov 23;22(1):440.
Results Reference
derived
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Short Duration High Intensity Intrapleural Alteplase With Pulmozyme in Pleural Infection Management
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