Staphylococcus Aureus PneumoniamucostaphNCT04171583
Mucoid Staphylococcus Aureus in Cystic Fibrosis Airways
An observational study of Staphylococcus Aureus Pneumonia and Lung Diseases, run by University Hospital Muenster at 13 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Staphylococcus Aureus Pneumonia, Lung Diseases, Cystic Fibrosis
- How many people
- 628 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 1 Mar 2019to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: CF patients with chronic S. aureus in respiratory specimens
Who may be able to join
- CF patients with chronic S. aureus in respiratory specimens (50% positive S. aureus cultures within one or two years before recruitment)
Who cannot join
- none
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Germany12 sites
University Hospital Ruhr University Bochum
Bochum
University Hospital Cologne
Cologne
Ruhrlandklinik Essen
Essen
University Hospital Essen
Essen
University Hospital Halle
Halle
Medizinische Hochschule Hannover
Hanover
LMU München
München
University Hospital Muenster
Münster, 48149
Clemenshospital
Münster
University Hospital Rostock
Rostock
University Hospital Tübingen
Tübingen
University Hospital Würzburg
Würzburg
About this study
Official title: 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.
Read the detailed description
- 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.
- Keywords
- cystic fibrosis, staphylococcus aureus, mucoid
- Medical subject headings
- Pneumonia, Staphylococcal, Lung Diseases, Cystic Fibrosis, Respiratory Insufficiency, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mucoid S. aureus | CF patients with mucoid S. aureus | |
| non-mucoid S. aureus | CF patients with non-mucoid S. aureus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Mar 2019
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Staphylococcus Aureus PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Kahl, University Hospital Muenster
- Investigators
- Barbara C Kahl, MD, Principal investigator, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171583
- Sponsor's protocol ID
- MZM study
- Acronym
- mucostaph
- Status last verified
- Feb 2023
- First submitted
- 15 Nov 2019
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39918841
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Mucoid Staphylococcus Aureus Recovered From the Airways of Cystic Fibrosis Patients: Prevalence and Impact on Clinical Course
- ClinicalTrials.gov ID
- NCT04171583
- Acronym / sponsor ID
- mucostaph / MZM study
- Keywords
- cystic fibrosis, staphylococcus aureus, mucoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mucoid S. aureus | – | –CF patients with mucoid S. aureus |
| non-mucoid S. aureus | – | –CF patients with non-mucoid S. aureus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CF patients with chronic S. aureus in respiratory specimens
Key inclusion criteria (1 listed)
- CF patients with chronic S. aureus in respiratory specimens (50% positive S. aureus cultures within one or two years before recruitment)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Derived from this study: PubMed 39918841Rumpf 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara C Kahl, MD principal investigator
University Hospital Muenster
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcus Aureus Pneumonia and Lung Diseases, run by University Hospital Muenster at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04171583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.