Mucoid Staphylococcus Aureus in Cystic Fibrosis Airways

Completed

• Conditions: Lung Diseases; Cystic Fibrosis; Lung Function Decreased; Staphylococcus Aureus Pneumonia

• Registration Number: NCT04171583
• Lead Sponsor: University Hospital Muenster

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 628

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lung function of patients with mucoid S. aureus will be compared to age and gender matched patients with only normal S. aureus	one year	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

Trial Locations

Locations (13)

University Hospital Wien; 🇦🇹 Wien, Austria

Ruhrlandklinik Essen; 🇩🇪 Essen, Germany

University Hospital Halle; 🇩🇪 Halle, Germany

LMU München; 🇩🇪 München, Germany

University Hospital Cologne; 🇩🇪 Cologne, Germany

University Hospital Essen; 🇩🇪 Essen, Germany

University Hospital Würzburg; 🇩🇪 Würzburg, Germany

University Hospital Ruhr University Bochum; 🇩🇪 Bochum, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

University Hospital Muenster; 🇩🇪 Münster, Germany

University Hospital Rostock; 🇩🇪 Rostock, Germany

Clemenshospital; 🇩🇪 Münster, Germany

University Hospital Tübingen; 🇩🇪 Tübingen, Germany