Mucoid Staphylococcus Aureus in Cystic Fibrosis Airways (mucostaph)

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: Barbara C Kahl, MD; Phone Number: 55358 0049-251-83; Email: kahl@uni-muenster.de

Study Locations

• Austria
  • Wien, Austria
    • Recruiting
    • University Hospital Wien
    • Contact: Sabine Renner, MD
• Germany
  • Essen, Germany
    • Recruiting
    • University Hospital Essen
    • Contact: Florian Stehling, MD
  • München, Germany
    • Recruiting
    • LMU Munchen
    • Contact: Susanne Nährig
  • Münster, Germany, 48149
    • Recruiting
    • University Hospital Muenster
    • Contact: Angelika Duebbers, MD; Phone Number: 47746 0049-251-83
  • Münster, Germany
    • Recruiting
    • Clemenshospital
    • Contact: Peter Küster, MD
  • Rostock, Germany
    • Recruiting
    • University Hospital Rostock
    • Contact: Manfred Ballmann, MD
  • Tübingen, Germany
    • Recruiting
    • University Hospital Tübingen
    • Contact: Uta Graepla-Mainka, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

CF patients with chronic S. aureus in respiratory specimens

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
mucoid S. aureus; CF patients with mucoid S. aureus
non-mucoid S. aureus; CF patients with non-mucoid S. aureus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Investigators: Principal Investigator: Barbara C Kahl, MD, University Hospital Muenster

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): May 31, 2021

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: cystic fibrosis; staphylococcus aureus; mucoid
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Pancreatic Diseases; Fibrosis; Lung Diseases; Cystic Fibrosis; Staphylococcal Infections; Pneumonia, Staphylococcal
• Other Study ID Numbers: MZM study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No