Mucoid Staphylococcus Aureus in Cystic Fibrosis Airways

Cystic Fibrosis Clinical Trial

— mucostaph  

Official title:

Characterisation of Mucoid Staphylococcus Aureus Recovered From the Airways of Cystic Fibrosis Patients: Prevalence and Impact on Clinical Course

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04171583
• Other study ID #: MZM study
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: February 2023
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Recently, the investigators described a new mucoid phenotype of Staphylococcus aureus cultured from the airways of cystic fibrosis (CF) patients.In this observational study, the investigators plan to determine the prevalence of mucoid S. aureus in respiratory specimens of CF patients and a possible impact of mucoid S. aureus on lung disease severity.

Description:

S. aureus is one of the first isolated pathogens recovered from the airways of CF patients. In many patients, S. aureus persists for decades in spite of antibiotic treatment and host defence. During persistence in the airways, S. aureus needs to adapt to this hostile niche. Just recently, the investigators described mucoid S. aureus isolates as a so far not reported phenotype recovered from the airways of CF patients. These mucoid isolates carried a 5bp-deletion in a part of the "intercellular adhesion operon (ica) leading to hyper-expression of biofilm. So far, neither the prevalence of mucoid S. aureus nor the impact on lung disease in CF patients is known. The investigators plan to perform a clinical study to determine the prevalence of mucoid S. aureus isolates in a cross-sectional study and the impact of identified mucoid S. aureus on the clinical course of the lung disease by observing patients with mucoid S. aureus for 12 months in comparison with a group of age-, gender- and P. aeruginosa-positive/negative matched group of S. aureus-positive patients without mucoid isolates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• CF patients with chronic S. aureus in respiratory specimens (50% positive S. aureus cultures within one or two years before recruitment)

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Lung Diseases
• Lung Function Decreased
• Pneumonia, Staphylococcal
• Staphylococcal Infections
• Staphylococcus Aureus Pneumonia

Locations

Country	Name	City	State
Austria	University Hospital Wien	Wien
Germany	University Hospital Ruhr University Bochum	Bochum
Germany	University Hospital Cologne	Cologne
Germany	Ruhrlandklinik Essen	Essen
Germany	University Hospital Essen	Essen
Germany	University Hospital Halle	Halle
Germany	Medizinische Hochschule Hannover	Hannover
Germany	LMU München	München
Germany	Clemenshospital	Münster
Germany	University Hospital Muenster	Münster
Germany	University Hospital Rostock	Rostock
Germany	University Hospital Tübingen	Tübingen
Germany	University Hospital Würzburg	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lung function of patients with mucoid S. aureus will be compared to age and gender matched patients with only normal S. aureus	lung function assessed by FEV1% predicted, which is performed during the visits at the cystic fiboris center, will be reported in case report forms to the investigator	one year