Mucoid Staphylococcus Aureus in Cystic Fibrosis Airways

NCT ID: NCT04171583

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 628 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2022-07-31

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.

Conditions

Staphylococcus Aureus Pneumonia; Lung Diseases; Cystic Fibrosis; Lung Function Decreased

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

mucoid S. aureus

CF patients with mucoid S. aureus

No interventions assigned to this group

non-mucoid S. aureus

CF patients with non-mucoid S. aureus

No interventions assigned to this group

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Barbara Kahl

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara C Kahl, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Muenster

Locations

University Hospital Wien

Vienna, , Austria

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

Hanover, , Germany

LMU München

München, , Germany

University Hospital Muenster

Münster, , Germany

Clemenshospital

Münster, , Germany

University Hospital Rostock

Rostock, , Germany

University Hospital Tübingen

Tübingen, , Germany

University Hospital Würzburg

Würzburg, , Germany

Countries

Austria; Germany

Other Identifiers

MZM study

Identifier Type: -

Identifier Source: org_study_id