Loculated EmpyemaNCT04915586
Short Duration High Intensity Intrapleural Alteplase With Pulmozyme in Pleural Infection Management
A study testing Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg in people with Loculated Empyema, run by National University of Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Loculated Empyema
- What is being tested?
- Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 Dec 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Kebangsaan Malaysia Medical Centre
Cheras, Kuala Lumpur, 56000
About this study
Official title: Short Duration High Intensity Intrapleural Alteplase With Pulmozyme (DNase) in Pleural Infection Management- Single Centre Experience
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.
Read the 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.
- Conditions
- Loculated Empyema
- Being tested
- Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg
- Keywords
- Intrapleural fibrinolysis, pleural infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mgDrug
Also called Combination Tissue Plasminogen Activator (t-PA) and Pulmozyme (DNase)
Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours
Intervention Drug: Combination Alteplase and pulmozyme (DNase) Receives: Drug: Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic improvement in pleural opacity on chest radiograph
measured in percentage
Measured: Day 7
Secondary outcomes (7)
pleural fluid volume drained
measured in mls
Measured: Day 7
changes in inflammatory markers C-Reactive Protein (CRP )
reduction of inflammatory markers trend
Measured: Day 7
White cell count
changes in inflammatory markers trend
Measured: Day 7
length of hospitalisation
days
Measured: upto 30 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
Measured: upto 30 days
adverse events post therapy
pain, bleeding events, hemodynamic stability
Measured: Day 7
mortality rate at day 30 post intervention
days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start30 Dec 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Loculated EmpyemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Faisal Abdul Hamid, National University of Malaysia
- Investigators
- Mohamed Faisal Abdul Hamid, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915586
- Sponsor's protocol ID
- FF-2020-008
- Other IDs
- NMRR-19-2940-51404
- Status last verified
- Jun 2021
- First submitted
- 21 Feb 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 35581627
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Duration High Intensity Intrapleural Alteplase With Pulmozyme (DNase) in Pleural Infection Management- Single Centre Experience
- ClinicalTrials.gov ID
- NCT04915586
- Acronym / sponsor ID
- FF-2020-008
- Conditions
- Loculated Empyema
- Keywords
- Intrapleural fibrinolysis, pleural infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mgIntra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours Intervention Drug: Combination Alteplase and pulmozyme (DNase) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mgAlso: Combination Tissue Plasminogen Activator (t-PA) and Pulmozyme (DNase)Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours | Drug | Treatment Arm |
Primary outcome
Radiographic improvement in pleural opacity on chest radiograph
Time frame: Day 7
measured in percentage
7 secondary outcomes
pleural fluid volume drained
Time frame: Day 7
changes in inflammatory markers C-Reactive Protein (CRP )
Time frame: Day 7
White cell count
Time frame: Day 7
length of hospitalisation
Time frame: upto 30 days
the need of surgical referral
Time frame: upto 30 days
adverse events post therapy
Time frame: Day 7
mortality rate at day 30 post intervention
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Derived from this study: PubMed 35581627Cheong 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.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Faisal Abdul Hamid principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg in people with Loculated Empyema, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic improvement in pleural opacity on chest radiograph (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04915586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.