Methicillin-resistant Staphylococcus aureus (MRSA) eradication in Cystic Fibrosis patients: influence on lung function values

ISRCTN	ISRCTN69078742
DOI	https://doi.org/10.1186/ISRCTN69078742
Secondary identifying numbers	B.U.N.143201213745

Submission date: 22/01/2013
Registration date: 03/04/2013
Last edited: 13/08/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Cystic fibrosis (CF) is an inherited disease that affects the internal organs, mainly the lungs and digestive system. Respiratory infections are an important cause of morbidity in CF patients. With increasing survival due to improvements of care, an increased frequency of pulmonary infections with new and resistant pathogens has been identified. In particular, the prevalence of methicillin-resistant Staphyylococcus aureus (MRSA) in respiratory cultures of CF patients has increased over the past decade. Because MRSA infection can have a negative impact on lung function values, antibiotic treatment is initiated when MRSA is found and the treatment removes ('eradicates') MRSA from the respiratory tract.
This study aims to investigate the influence of MRSA eradication on lung function values.

Who can participate?
Patients with CF, aged over 6 years old and with MRSA found in the respiratory culture

What does the study involve?
Patients will receive a combination of 2 antibiotics, during 6 months. Respiratory samples will be analysed after 3 and 6 months, and at 3 and 6 months after eradication was completed. Lung function will be measured before start of eradication, at 3 and 6 months after start of eradication, and at 3 and 6 months after completion of eradication.

What are the possible benefits and risks of participating?
The treatment used in this study has been studied before and has been proven to be safe and effective. Possible side effects are gastro-intestinal complaints.
New insights gained from this study will improve the understanding of the influence of MRSA infection on lung function.

Where is the study run from?
The CF reference centre at the University Hospital (Universitair Ziekenhuis Brussel) in Brussels, Belgium.

When is the study starting and how long is it expected to run for?
Patient recruitment started in June 2012 and the study will run until June 2015.

Who is funding the study?
Universitair Ziekenhuis Brussel, Brussels, Belgium

Who is the main contact?
Dr. Eef Vanderhelst
eef.vanderhelst@uzbrussel.be

Contact information

Dr Eef Vanderhelst
Scientific

Universitair Ziekenhuis Brussel
Laarbeeklaan 101
Brussels
1090
Belgium

Study information

Study design	Single-centre prospective open label study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	MRSA eradication in Cystic Fibrosis: treatment protocol and impact on lung function decline and lung clearance index
Study objectives	Chronic methicillin-resistant Staphyylococcus aureus (MRSA) infection is associated with a faster lung function decline in cystic fibrosis (CF) patients. We want to investigate the influence of MRSA eradication on lung function decline and lung clearance index. In addition, we want to evaluate the efficiency of the used antibiotics scheme.
Ethics approval(s)	Medical Ethics Committee UZ Brussel, 29 March 2012, Reference number: 2012/079
Health condition(s) or problem(s) studied	Cystic fibrosis - MRSA infection
Intervention	Treatment of MRSA infection: Decolonisation (nasal Mupirocin and Chlorhexidin soap and throat spray): every day during 5 days Peroral antibiotics (Fusidic acid and Rifampicin): every day during 6 months Measurement of lung function (including Lung Clearance Index, LCI) and analysis of respiratory samples at different time points: D0, after 3 and 6 months, and 3 and 6 months after stop of eradication.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Mupirocin, Chlorhexidin, Fusidic acid, Rifampicin
Primary outcome measure	Eradication of MRSA from the respiratory samples during and after completion of eradication
Secondary outcome measures	1. Lung function values (including LCI) 2. Clinical status
Overall study start date	01/06/2012
Completion date	01/06/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	25
Total final enrolment	11
Key inclusion criteria	1. Cystic fibrosis (CF) patients (diagnosis confirmed by sweat test) 2. Age greater than 6 years - 60 years, either sex 3. Newly acquired MRSA
Key exclusion criteria	1. Lung transplantation 2. Pregnancy
Date of first enrolment	01/06/2012
Date of final enrolment	01/06/2015

Locations

Countries of recruitment

Belgium

Study participating centre

Universitair Ziekenhuis Brussel

Brussels
1090
Belgium

Sponsor information

University Hospital Brussels (Universitair Ziekenhuis Brussel [UZ Brussel]) (Belgium)
Hospital/treatment centre

Laarbeeklaan 101
Brussels
1090
Belgium

Website	http://www.uzbrussel.be
"ROR"	https://ror.org/038f7y939

Funders

Funder type

Hospital/treatment centre

University Hospital Brussels (Universitair Ziekenhuis Brussel [UZ Brussel]) (Belgium)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2013	13/08/2020	Yes	No

Editorial Notes

13/08/2020: Publication reference and total final enrolment number.