NCT04171583

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
628

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

February 2, 2023

Status Verified

February 1, 2023

Enrollment Period

3.4 years

First QC Date

November 15, 2019

Last Update Submit

February 1, 2023

Conditions

Staphylococcus Aureus PneumoniaLung DiseasesCystic FibrosisLung Function Decreased

Keywords

cystic fibrosisstaphylococcus aureusmucoid

Outcome Measures

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

    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

Study Arms (2)

mucoid S. aureus

CF patients with mucoid S. aureus

non-mucoid S. aureus

CF patients with non-mucoid S. aureus

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

CF patients with chronic S. aureus in respiratory specimens

You may qualify if:

  • CF patients with chronic S. aureus in respiratory specimens (50% positive S. aureus cultures within one or two years before recruitment)

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University Hospital Wien

Vienna, Austria

Location

University Hospital Ruhr University Bochum

Bochum, Germany

Location

University Hospital Cologne

Cologne, Germany

Location

Ruhrlandklinik Essen

Essen, Germany

Location

University Hospital Essen

Essen, Germany

Location

University Hospital Halle

Halle, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

LMU München

München, Germany

Location

University Hospital Muenster

Münster, 48149, Germany

Location

Clemenshospital

Münster, Germany

Location

University Hospital Rostock

Rostock, Germany

Location

University Hospital Tübingen

Tübingen, Germany

Location

University Hospital Würzburg

Würzburg, Germany

Location

Related Publications (1)

  • Rumpf CH, Janssen T, Hait RJ, Romme K, Decker C, Peters J, Czowalla C, Deiwick S, Gorlich D, Dubbers A, Grosse-Onnebrink J, Kessler C, Kuster P, Schultingkemper H, Hebestreit H, Graepler-Mainka U, van Koningsbruggen-Rietschel S, Schildberg T, Renner S, Nahrig S, Wollschlager B, Schlegtendal A, Sutharsan S, Stehling F, Junge S, Ballmann M, Schwartbeck B, Kahl BC. Mucoid Staphylococcus aureus: A Clinical Trial of Its Prevalence and Association with Lung Function in People with Cystic Fibrosis. Am J Respir Crit Care Med. 2025 May;211(5):854-865. doi: 10.1164/rccm.202407-1474OC.

    PMID: 39918841DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

respiratory specimens: throat swabs, sputum

MeSH Terms

Conditions

Pneumonia, StaphylococcalLung DiseasesCystic FibrosisRespiratory InsufficiencyStaphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPneumonia, BacterialPneumoniaRespiratory Tract InfectionsRespiratory Tract DiseasesPancreatic DiseasesDigestive System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesRespiration Disorders

Study Officials

  • Barbara C Kahl, MD

    University Hospital Muenster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 15, 2019

First Posted

November 21, 2019

Study Start

March 1, 2019

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

February 2, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)DE(12)