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NCT Number: NCT04171583

Mucoid Staphylococcus Aureus in Cystic Fibrosis Airways

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.

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Key information

Conditions

Staphylococcus Aureus Pneumonia Bacterial Infections Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Gram-Positive Bacterial Infections Infant, Newborn, Diseases Infections Lung Diseases Lung Function Decreased Pancreatic Diseases Pneumonia Pneumonia, Bacterial Pneumonia, Staphylococcal Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Staphylococcal Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Wien, Vienna, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. lung function of patients with mucoid S. aureus will be compared to age and gender matched patients with only normal S. aureus

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Official study title

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

Acronym: mucostaph

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 21, 2019
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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