Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/01/2013
Date assigned
03/04/2013
Last edited
03/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Eef Vanderhelst

ORCID ID

Contact details

Universitair Ziekenhuis Brussel
Laarbeeklaan 101
Brussels
1090
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

B.U.N.143201213745

Study information

Scientific title

MRSA eradication in Cystic Fibrosis: treatment protocol and impact on lung function decline and lung clearance index

Acronym

Study hypothesis

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

Medical Ethics Committee UZ Brussel, 29 March 2012, Reference number: 2012/079

Study design

Single-centre prospective open label study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Mupirocin, Chlorhexidin, Fusidic acid, Rifampicin

Primary outcome measures

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 trial start date

01/06/2012

Overall trial end date

01/06/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25

Participant exclusion criteria

1. Lung transplantation
2. Pregnancy

Recruitment start date

01/06/2012

Recruitment end date

01/06/2015

Locations

Countries of recruitment

Belgium

Trial participating centre

Universitair Ziekenhuis Brussel
Brussels
1090
Belgium

Sponsor information

Organisation

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

Sponsor details

Laarbeeklaan 101
Brussels
1090
Belgium

Sponsor type

Hospital/treatment centre

Website

http://www.uzbrussel.be

Funders

Funder type

Hospital/treatment centre

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes