None listed
Conditions
Brief summary
Malignant Pleural Effusion (MPE) can complicate most cancers and commonly causes disabling breathlessness and impairs quality of life. Patients who develop MPE often have an indwelling pleural catheter (IPC) inserted to drain excess fluid from their lungs, however these catheters can increase patients' risk of infection. This study aims to assess the use of regular preventative antibiotic cream on the incidence of infections for patients with MPE who have been fitted with an IPC. Who is it for? You may be eligible for this study if you are aged 19 years or older, you require insertion of an IPC for the control of malignant pleural effusion and you are willing to comply with the research procedures. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. The first group will be given antibiotic cream to apply around the insertion site for their catheter, together with instructions on how to care for their catheter, how to change the catheter and dressings and how to apply the antibiotic cream. The first group will be asked to apply the antibiotic cream after each catheter drain for up to 6 months. The second group will not be given antibiotic cream but will be given instructions on how to care for their catheter and how to change the catheter and dressings. Both groups will receive standard care from their treating physician throughout the study, including access to support services (e.g. direct phone line). All participants and carers will have the support and care of the respiratory unit. They will have access to the respiratory research staff via a direct phone line should any concerns arise. It is hoped this research will demonstrate whether using preventative antibiotics prior to an infection occurring reduces the number, type and severity of infections that patients with an indwelling pleural catheter may experience. If this study does show a positive impact on the infection rate, it may be expanded to a larger number of patients with indwelling pleural catheters to improve their quality of life.
Interventions
Participants will be randomly assigned (1:1) to either:
a. Topical mupirocin
Topical mupirocin 2% cream will be applied around the exit-site of the indwelling pleural catheter (IPC) for an area approximating a 50 cents coin. An information sheet with a picture of how to apply the cream will be provided to patients/carers. The antibiotics should be applied after each drainage but at least twice weekly (with dressing change) even if draining less frequently for 6 months or until IPC is removed,
Participants will be randomly assigned (1:1) to either: a. Topical mupirocin Topical mupirocin 2% cream will be applied around the exit-site of the indwelling pleural catheter (IPC) for an area approximating a 50 cents coin. An information sheet with a picture of how to apply the cream will be provided to patients/carers. The antibiotics should be applied after each drainage but at least twice weekly (with dressing change) even if draining less frequently for 6 months or until IPC is removed, whichever is earlier. Compliance is monitored via weekly phone calls to the patient or nurse. Mupirocin is a topical antibiotic used worldwide for decades with a strong safety record. It binds specifically to bacterial isoleucyl transfer-RNA synthetase and inhibits bacterial protein synthesis. b. No topical mupirocin (standard care) Standard Care Participants in both arms will be managed by their own clinical teams and receive all other medical treatments (including chemotherapy and radiotherapy) as deemed clinically appropriate. Patients’ medical care, including IPC care, oncology management etc, will be directed by their attending physicians, as per standard practice in the treatment hospital, regardless of study group allocation. This includes the frequency of drainage, drainage device (suction bottle or drainage bag), administration of talc pleurodesis via IPC, etc. All patients will receive standard education on IPC aftercare, have access to support services (eg direct phone line) and standard care from their attending physicians, eg chemo-irradiation and immunotherapy. Decision of IPC removal is made by the physicians in-charge. Generally, IPC can be removed if drainage is <50mL on 3 consecutive drainages and there is no significant fluid accumulation on imaging. All participants and carers will have the support and care of the respiratory unit. They will have access to the respiratory research staff via a direct phone line should any concerns arise.
Sponsors
Institute for Respiratory Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who require insertion of an IPC for control of malignant pleural effusion (MPE). °MPE is defined as an effusion in which cancer cells are identified in the fluid or pleural biopsy; or is a large exudative effusion without other causes in a patient with advanced disseminated malignancy.
Exclusion criteria
1. Age <18 yrs 2. Allergy to mupirocin 3. Ipsilateral pleural infection within past three months 4. Inability to consent 5. Inability to comply with the protocol.
Outcome results
None listed