Clinical trial NCT04915586: 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
Overall status: COMPLETED
Phase: NA
Conditions: Loculated Empyema
Keywords: Intrapleural fibrinolysis, pleural infection
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Radiographic improvement in pleural opacity on chest radiograph
timeFrame: Day 7
Secondary outcomes:
measure: pleural fluid volume drained
timeFrame: Day 7
measure: changes in inflammatory markers C-Reactive Protein (CRP )
timeFrame: Day 7
measure: White cell count
timeFrame: Day 7
measure: length of hospitalisation
timeFrame: upto 30 days
measure: the need of surgical referral
timeFrame: upto 30 days
measure: adverse events post therapy
timeFrame: Day 7
measure: mortality rate at day 30 post intervention
timeFrame: 30 days
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: University Kebangsaan Malaysia Medical Centre
state: Kuala Lumpur
Study officials:
affiliation: Associate Professor
name: Mohamed Faisal Abdul Hamid
role: PRINCIPAL_INVESTIGATOR
References:
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.