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

NCT ID: NCT04915586

Last Updated: 2021-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-30
• Study Completion Date: 2020-12-31

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.

Conditions

Loculated Empyema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours

Intervention Drug: Combination Alteplase and pulmozyme (DNase)

Group Type: EXPERIMENTAL

Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg

Intervention Type: DRUG

Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours

Interventions

Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg

Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours

Intervention Type: DRUG

Other Intervention Names

Combination Tissue Plasminogen Activator (t-PA) and Pulmozyme (DNase)

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University of Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Faisal Abdul Hamid

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Faisal Abdul Hamid

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

University Kebangsaan Malaysia Medical Centre

Cheras, Kuala Lumpur, Malaysia

Countries

Malaysia

References

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.

Reference Type: DERIVED

PMID: 35581627 (View on PubMed)

Other Identifiers

NMRR-19-2940-51404

Identifier Type: REGISTRY

Identifier Source: secondary_id

FF-2020-008

Identifier Type: -

Identifier Source: org_study_id