Clinical trial NCT04171583: Mucoid Staphylococcus Aureus in Cystic Fibrosis Airways
Official title: Characterisation of Mucoid Staphylococcus Aureus Recovered From the Airways of Cystic Fibrosis Patients: Prevalence and Impact on Clinical Course
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Staphylococcus Aureus Pneumonia
Lung Diseases
Cystic Fibrosis
Lung Function Decreased
Keywords: cystic fibrosis
staphylococcus aureus
mucoid
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 628
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CF patients with chronic S. aureus in respiratory specimens

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.

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

Primary outcomes:
measure: lung function of patients with mucoid S. aureus will be compared to age and gender matched patients with only normal S. aureus
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Wien
country: Austria
facility: University Hospital Wien
city: Bochum
country: Germany
facility: University Hospital Ruhr University Bochum
city: Cologne
country: Germany
facility: University Hospital Cologne
city: Essen
country: Germany
facility: Ruhrlandklinik Essen
city: Essen
country: Germany
facility: University Hospital Essen
city: Halle
country: Germany
facility: University Hospital Halle
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: München
country: Germany
facility: LMU München
city: Münster
country: Germany
facility: University Hospital Muenster
city: Münster
country: Germany
facility: Clemenshospital
city: Rostock
country: Germany
facility: University Hospital Rostock
city: Tübingen
country: Germany
facility: University Hospital Tübingen
city: Würzburg
country: Germany
facility: University Hospital Würzburg
Study officials:
affiliation: University Hospital Muenster
name: Barbara C Kahl, MD
role: PRINCIPAL_INVESTIGATOR
References: