Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001280796
Ethics application status
Approved
Date submitted
18/08/2022
Date registered
29/09/2022
Date last updated
29/09/2022
Date data sharing statement initially provided
29/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind, placebo controlled randomised study to assess the tolerability, safety, and preliminary efficacy of taurolidine-citrate lock solution (TauroLock™) in patients with recurrent pleural effusions requiring management with Indwelling Pleural Catheters for recurrent effusion drainage.
Scientific title
A double-blind, placebo controlled randomised study to assess the tolerability, safety, and preliminary efficacy of taurolidine-citrate lock solution (TauroLock™) in patients with recurrent pleural effusions requiring management with Indwelling Pleural Catheters for recurrent effusion drainage.
Secondary ID [1] 307836 0
None
Universal Trial Number (UTN)
Trial acronym
POPIT (Prevention of Pleural infection and catheter blockage with Taurolidine-citrate solution)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent pleural effusion 327360 0
pleural infection 327361 0
Condition category
Condition code
Respiratory 324484 324484 0 0
Other respiratory disorders / diseases
Infection 324563 324563 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A syringe containing 5ml of TauroLock™ solution (Taurolidine 1%-citrate 4%) or placebo (0.9% sodium chloride) will be used as test drug/placebo in this study. Patients will be randomised to receive either test drug or placebo first. 2.5ml of solution will be instilled into the indwelling pleural catheter within 7 days of insertion (immediately following pleural drainage) and repeated 4 weeks later (with the taurolidine-citrate/placebo, whichever they did not receive). TauroLock/placebo will be instilled twice to each patient ie. each patient will receive both TauroLock and placebo 4 weeks apart.

This will be performed by clinical research fellow and documented in medication chart at the time of intervention.
Intervention code [1] 324245 0
Treatment: Drugs
Intervention code [2] 324517 0
Prevention
Comparator / control treatment
Placebo - 0.9% sodium chloride (normal saline). Patients will be their own controls and receive both test drug and placebo 4 weeks apart.
Control group
Placebo

Outcomes
Primary outcome [1] 332309 0
Change in Visual analogue scale (VAS) pain score pre- and post-instillation of Taurolock compared with placebo.
Timepoint [1] 332309 0
Pre-instillation of TauroLock,and 1 hour post-TauroLock instillation, 24-72 hours post instillation
Secondary outcome [1] 412943 0
Proportion of instillations of Taurolidine-citrate compared to placebo that meet criteria for tolerability defined as patient would be willing to undergo a further instillation of the same liquid (drug or placebo) again at the time of their next indwelling pleural catheter (IPC) drainage.
Ie. proportion of patients who select yes when asked if they would be willing to undergo a further instillation of (drug or placebo) again at the time of their next indwelling pleural catheter (IPC) drainage.
Timepoint [1] 412943 0
24 to 72 hours post instillation, 4 weeks post instillation
Secondary outcome [2] 412944 0
Incidence rates of positive pleural fluid bacterial culture follow up in patients that received Taurolidine-citrate prior to fluid sampling, compared with those that received placebo. Assessed by medical records review.
Timepoint [2] 412944 0
4 weeks post instillation and 8 weeks post instillation
Secondary outcome [3] 412946 0
Mean incremental change in pre- and post-instillation VAS pain scores with Taurolidine-citrate compared to placebo. Percentage change from baseline compared with placebo.
Timepoint [3] 412946 0
Week 0 and 4 post-instillation of drug
Secondary outcome [4] 412947 0
Proportion of patients that develop pleurodesis - assessed by ability to remove indwelling pleural catheter without additional pleural procedures being required in next 30 days determined by medical review.
Timepoint [4] 412947 0
3 months - post-enrolment to trial
Secondary outcome [5] 412948 0
Mean incremental change in overall Quality of Life on 100mm VAS scale.
Timepoint [5] 412948 0
0 weeks, 4 weeks, 8 weeks and 3 months post-enrolment compared to Day 0 post enrolment
Secondary outcome [6] 412949 0
Composite outcome: Indwelling pleural catheter related pleural or chest wall infections post procedure- this will be reviewed clinically at the time of each clinical review and from medical records review.
Timepoint [6] 412949 0
3 months post-enrolment
Secondary outcome [7] 412950 0
Incidence of indwelling pleural catheter blockage - assessed by clinical review and medical records review at the time of each follow up visit.
Timepoint [7] 412950 0
3 months post enrolment
Secondary outcome [8] 412951 0
Incidence of catheter tract metastases - assessed based on medical records review
Timepoint [8] 412951 0
3 months post enrolment
Secondary outcome [9] 412952 0
Indwelling pleural catheter pleural fluid citrate and ionised calcium concentrations reviewed by medical record review from pathology results.
Timepoint [9] 412952 0
Prior to instillation (pre-pleural effusion drainage) and at next IPC drainage (24-72 hours post-instillation)
Secondary outcome [10] 412953 0
Haemothorax requiring blood product transfusion - assessed by medical records review and clinical discussion at time of review
Timepoint [10] 412953 0
3 months post enrolment
Secondary outcome [11] 412954 0
IPC removal assessed by medical record review
Timepoint [11] 412954 0
3 months post-enrolment
Secondary outcome [12] 412955 0
Hospitalisation- pleural effusion related - assessed medical records review
Timepoint [12] 412955 0
3 months- post enrolment
Secondary outcome [13] 412956 0
Pleural effusion related adverse events and serious adverse events - assessed on clinical review with participant reported adverse events, medical records review
Timepoint [13] 412956 0
3 months post-enrolment
Secondary outcome [14] 412957 0
Other adverse events - participant self-reported during clinical review, medical records review. For example, nausea/vomiting,
Timepoint [14] 412957 0
3 months- post enrolment
Secondary outcome [15] 412958 0
Death - medical records review,
Timepoint [15] 412958 0
3 months post-enrolment

Eligibility
Key inclusion criteria
1. Patients with an Indwelling Pleural Catheter (IPC) for recurrent pleural effusion who consent to the trial.
2. Must be within community nursing service catchment (e.g. Silver Chain) and be able to attend follow up appointments at SJOG Midland as required.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients unable to provide informed consent
2. Life expectancy <3 months
3. Known adverse reaction to taurolidine or citrate
4. Patient requiring other intrapleural medication
5. Active bleeding of sufficient severity to warrant hospital admission or withholding of regular anticoagulation therapy
6. Severe renal impairment (eGFR <30)
7. Concurrent pregnancy, lactation
8. Patients with previous documented pleural infection within 6 months
9. Uncontrolled pain at baseline

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Intention to treat and per protocol basis.
Univariate comparison of patient baseline characteristics between study groups will consist of paired t-tests or Mann-Whitney U tests based on normally distributed and non-parametric data respectively, Chi-squared tests or Fisher exact tests for categorical data.
The effects of intervention on the pain score and longitudinal data of VAS scales between two groups will be assessed using Generalised Linear Mixed Models (GLMM) with appropriate model links and adjusting for confounders and other relevant patient characteristics, with results summarised as marginal means and 95% confidence intervals (CI’s).
which might include methods for multiple imputation for missing VAS scores.
The proportion of death and hospitalization and also frequencies of SAE’s and PERSAE’s will be compared using chi square tests or Fisher exact test. Time to death, hospitalization as a result of SAE will be analysed using log rank tests and Co proportional hazards, with hazard ratios and 95 % CI represented.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2022
Actual
Date of last participant enrolment
Anticipated
1/09/2024
Actual
Date of last data collection
Anticipated
15/12/2024
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 22975 0
St John of God Midland Public Hospital - Midland
Recruitment postcode(s) [1] 38282 0
6056 - Midland

Funding & Sponsors
Funding source category [1] 312052 0
Hospital
Name [1] 312052 0
St John of God Midland Hospital
Country [1] 312052 0
Australia
Primary sponsor type
Hospital
Name
St John of God Midland Hospital
Address
1 Clayton Street, Midland, WA 6056
Country
Australia
Secondary sponsor category [1] 313557 0
None
Name [1] 313557 0
None
Address [1] 313557 0
Country [1] 313557 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311464 0
HREC St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 311464 0
Ethics committee country [1] 311464 0
Australia
Date submitted for ethics approval [1] 311464 0
11/07/2022
Approval date [1] 311464 0
15/08/2022
Ethics approval number [1] 311464 0
1971

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121186 0
Dr Ed Fysh
Address 121186 0
St John of God Midland
1 Clayton Street,
Midland
6056
WA
Country 121186 0
Australia
Phone 121186 0
+61 423688261
Fax 121186 0
Email 121186 0
[email protected]
Contact person for public queries
Name 121187 0
Charlotte Wigston
Address 121187 0
St John of God Midland Hospital
1 Clayton St
Midland
6056
WA
Country 121187 0
Australia
Phone 121187 0
+61 422271726
Fax 121187 0
Email 121187 0
[email protected]
Contact person for scientific queries
Name 121188 0
Charlotte Wigston
Address 121188 0
St John of God Midland Hospital
1 Clayton St
Midland
6056
WA
Country 121188 0
Australia
Phone 121188 0
+61 422271726
Fax 121188 0
Email 121188 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16969Ethical approval  [email protected] St John of God Ethical Approval 384532-(Uploaded-24-08-2022-11-02-08)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.