Cystic FibrosisStaphCINCT00669760
Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients
An observational study of Cystic Fibrosis, run by University Hospital Muenster at 17 sites in 2 countries.
Trial summary
Staphylococcus aureus is not only one of the first pathogens infecting the airways of cystic fibrosis (CF) patients, but also a highly prevalent microorganism (>60% of all CF patients; European and American CF registries; (4,25), which often persists for several years in the respiratory tract of CF patients. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- non-interventional study
- How many people
- 195 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Jul 2008to Jan 2015
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: CF-patients with persistent S. aureus culture in their airway specimens
Who may be able to join
- positive S. aureus cultures for more than 6 months within the last year; children (>6 years) and patients with CF, who are able to perform lung function tests
Who cannot join
- Pseudomonas aeruginosa and/or Burkholderia cepacia colonization or infection for more than 6 months within the last year before recruitment; patients who have not been colonized with these pathogens before but acquire them within the study period and are colonized/infected for more than 6 months during the observation period
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Germany16 sites
Charite Berlin Campus Benjamin Franklin
Berlin, 12200
Clinic for Children and Adolescents Ruhr University Bochum St Josef Hospital
Bochum, 44791
Universitätsklinikum Carl Gustav Carus
Dresden, 01307
Heinrich-Heine University Duesseldorf
Düsseldorf, 40225
University Clinics Essen
Essen, 45122
Ruhrlandklinik Essen-Heidhausen
Essen, 45239
Universitätsklinikum Halle
Halle, 06120
Dres Heuer-Runge-Sextro
Hamburg, 22763
Medical School Hannover
Hanover, 30625
University Clinics Jena
Jena, 07743
Children's Hospital Park Schoenfeld
Kassel, 34121
Universitätsklinikum Leipzig
Leipzig, 04103
University Clinics Muenster
Münster, 48149
Clemenshospital
Münster, 48153
Children's Hospital Osnabrueck
Osnabrück, 49082
University Clinics Tuebingen
Tübingen, 72076
About this study
Official title: Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients, a Non-interventional, Prospective, Longitudinal Multicenter Study.
Staphylococcus aureus is not only one of the first pathogens infecting the airways of cystic fibrosis (CF) patients, but also a highly prevalent microorganism (>60% of all CF patients; European and American CF registries; (4,25), which often persists for several years in the respiratory tract of CF patients.
The purpose of this study is to dissect infection by S. aureus from colonization. Therefore, the following non-interventional prospective, longitudinal multicenter study will be conducted to develop the following hypothesis:
Read more
CF patients with high bacterial loads are more likely to be infected by S. aureus than patients with low bacterial loads.
Primary endpoint: bacterial load of sputum cultures
Secondary endpoints:
- nasal carriage
- molecular analysis of S. aureus (Monoclonal/polyclonal)
- serum: S. aureus-specific antibodies, S100A12, IL-8, TNF-alpha
- sputum: S100A12, IL-8, myeloperoxidase
- S. aureus therapy regimens
- lung function tests: FEV1, deltaFVC , deltaMEF25
- BMI development
Inclusion criteria: S. aureus cultures for more than 6 months within the last year, children (>6 years) and patients, who are able to perform lung function tests Exclusion criteria: P. aeruginosa and/or B. cepacia cultures from the specimens for more than 6 months within the last year before recruitment or during the study period In addition to microbiological investigations and clinical laboratory tests, the actual clinical situation will be evaluated and reported during the study period. The results of this observational study will be used to carefully plan a clinical interventional study. Furthermore, with the results it might be possible to characterize a subpopulation of patients, which is at greater risk for S. aureus infections.
Read the detailed description
Protocol synopsis Title: Dissection of Staphylococcus aureus infection from colonization in cystic fibrosis patients. A non-interventional prospective, 2-year longitudinal multicenter study
Study objectives: The aim of the study is to dissect S. aureus infection from colonization of the pathogen in airway secretions of CF patients during a 2 year period by means of a non-interventional, prospective, longitudinal multicenter study.
The following hypothesis will be developed:
CF patients with high bacterial loads are more likely to be infected by S. aureus than patients with low bacterial loads.
Definition of infection:
- change in volume, colour or consistency of sputum (exacerbation)
- increased cough
- malaise, fatigue or lethargy
- body temperature more than 38°C
- new or increased hemoptysis
- anorexia or weight loss
- sinus pain or tenderness
- change in sinus discharge
- change in chest sounds
- ten percent decrease in pulmonary function from a previous recorded value (FEV1, MEF25)
- radiographic changes indicative of pulmonary infection
Primary endpoint: bacterial load of sputum cultures [high (>/= 106CFU/ml); low (<106CFU/ml)]
Secondary endpoints are:
- assessment of nasal S. aureus carriage
- serum samples: antibody titres against S. aureus specific antigens; S100A12, IL-8,TNF-alpha, CRP
- molecular analysis of S. aureus colonization/infection (monoclonal or heteroclonal)
- sputa analysis: activity of S100A12, IL-8 and myeloperoxidase
- antibiotic treatment regimens against S. aureus
- body mass index
- lung function tests: FEV1, deltaFVC, deltaMEF25
Extensive microbiological investigations will be performed when the patients are seen at their regular visits in the outpatient clinics or if exacerbations occur. During the study period of 2 years, at least 8 visits to the outpatient clinic should be recorded. The following clinical parameters will be documented:
- lung function
- body mass index (weight/height)
- antibiotic treatment Diagnosis: CF and positive S. aureus cultures for more than 6 months within the last year Localisation of the study: multicenter study in Germany Number of centers: Seven centres agreed already to participate in the study. More centers have been and will be contacted.
Design: non-interventional prospective, longitudinal multicenter study Planned number of patients/volunteers: 228 Inclusion criteria: positive S. aureus cultures for more than 6 months within the last year; children (>6 years) and patients with CF, who are able to perform lung function tests Exclusion criteria: Pseudomonas aeruginosa and/or Burkholderia cepacia colonization or infection for more than 6 months within the last year before recruitment; patients who have not been colonized with these pathogens before but acquire them within the study period and are colonized/infected for more than 6 months during the observation period
- Conditions
- Cystic Fibrosis
- Being tested
- non-interventional study
- Keywords
- cystic fibrosis, Staphylococcus aureus, persistent colonization-infection, clinical status, lung function
- Medical subject headings
- Cystic Fibrosis, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventional studyOther
Also called does not apply
does not apply
| Study group | Role | What they receive |
|---|---|---|
| Observation | CF-patients with persistent culture of Staphylococcus aureus in their respiratory specimens Receives: Other: non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial load of sputum cultures [high (>/= 1000000CFU/ml); low (<1000000CFU/ml)]
Measured: 2 years
Secondary outcomes (1)
antibody titres against S. aureus specific antigens; S100A12, IL-8, TNF-alpha, CRP
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2011
- Study completionJan 2015
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 Cystic FibrosisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Mukoviszidose eV Bonn Germany
- Responsible party
- Principal investigator, Barbara Kahl, University Hospital Muenster
- Investigators
- Barbara C Kahl, MD, Principal investigator, Dept. Med. Microbiology, University Clinics Muenster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669760
- Sponsor's protocol ID
- Muko e.V. S05/07
- Acronym
- StaphCI
- Status last verified
- Jan 2015
- First submitted
- 28 Apr 2008
- Last updated
- 7 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Junge S, Gorlich D, den Reijer M, Wiedemann B, Tummler B, Ellemunter H, Dubbers A, Kuster P, Ballmann M, Koerner-Rettberg C, Grosse-Onnebrink J, Heuer E, Sextro W, Mainz JG, Hammermann J, Riethmuller J, Graepler-Mainka U, Staab D, Wollschlager B, Szczepanski R, Schuster A, Tegtmeyer FK, Sutharsan S, Wald A, Nofer JR, van Wamel W, Becker K, Peters G, Kahl BC. Factors Associated with Worse Lung Function in Cystic Fibrosis Patients with Persistent Staphylococcus aureus. PLoS One. 2016 Nov 18;11(11):e0166220. doi: 10.1371/journal.pone.0166220. eCollection 2016.
PubMed 27861524
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients, a Non-interventional, Prospective, Longitudinal Multicenter Study.
- ClinicalTrials.gov ID
- NCT00669760
- Acronym / sponsor ID
- StaphCI / Muko e.V. S05/07
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, Staphylococcus aureus, persistent colonization-infection, clinical status, lung function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Mukoviszidose eV Bonn Germany
- Study start
- Jul 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Apr 2008 (estimated)
- 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.
Staphylococcus aureus is not only one of the first pathogens infecting the airways of cystic fibrosis (CF) patients, but also a highly prevalent microorganism (>60% of all CF patients; European and American CF registries; (4,25), which often persists for several years in the respiratory tract of CF patients.
The purpose of this study is to dissect infection by S. aureus from colonization. Therefore, the following non-interventional prospective, longitudinal multicenter study will be conducted to develop the following hypothesis:
CF patients with high bacterial loads are more likely to be infected by S. aureus than patients with low bacterial loads.
Primary endpoint: bacterial load of sputum cultures
Secondary endpoints:
- nasal carriage
- molecular analysis of S. aureus (Monoclonal/polyclonal)
- serum: S. aureus-specific antibodies, S100A12, IL-8, TNF-alpha
- sputum: S100A12, IL-8, myeloperoxidase
- S. aureus therapy regimens
- lung function tests: FEV1, deltaFVC , deltaMEF25
- BMI development
Inclusion criteria: S. aureus cultures for more than 6 months within the last year, children (>6 years) and patients, who are able to perform lung function tests Exclusion criteria: P. aeruginosa and/or B. cepacia cultures from the specimens for more than 6 months within the last year before recruitment or during the study period In addition to microbiological investigations and clinical laboratory tests, the actual clinical situation will be evaluated and reported during the study period. The results of this observational study will be used to carefully plan a clinical interventional study. Furthermore, with the results it might be possible to characterize a subpopulation of patients, which is at greater risk for S. aureus infections.
Detailed description
Protocol synopsis Title: Dissection of Staphylococcus aureus infection from colonization in cystic fibrosis patients. A non-interventional prospective, 2-year longitudinal multicenter study
Study objectives: The aim of the study is to dissect S. aureus infection from colonization of the pathogen in airway secretions of CF patients during a 2 year period by means of a non-interventional, prospective, longitudinal multicenter study.
The following hypothesis will be developed:
CF patients with high bacterial loads are more likely to be infected by S. aureus than patients with low bacterial loads.
Definition of infection:
- change in volume, colour or consistency of sputum (exacerbation)
- increased cough
- malaise, fatigue or lethargy
- body temperature more than 38°C
- new or increased hemoptysis
- anorexia or weight loss
- sinus pain or tenderness
- change in sinus discharge
- change in chest sounds
- ten percent decrease in pulmonary function from a previous recorded value (FEV1, MEF25)
- radiographic changes indicative of pulmonary infection
Primary endpoint: bacterial load of sputum cultures [high (>/= 106CFU/ml); low (<106CFU/ml)]
Secondary endpoints are:
- assessment of nasal S. aureus carriage
- serum samples: antibody titres against S. aureus specific antigens; S100A12, IL-8,TNF-alpha, CRP
- molecular analysis of S. aureus colonization/infection (monoclonal or heteroclonal)
- sputa analysis: activity of S100A12, IL-8 and myeloperoxidase
- antibiotic treatment regimens against S. aureus
- body mass index
- lung function tests: FEV1, deltaFVC, deltaMEF25
Extensive microbiological investigations will be performed when the patients are seen at their regular visits in the outpatient clinics or if exacerbations occur. During the study period of 2 years, at least 8 visits to the outpatient clinic should be recorded. The following clinical parameters will be documented:
- lung function
- body mass index (weight/height)
- antibiotic treatment Diagnosis: CF and positive S. aureus cultures for more than 6 months within the last year Localisation of the study: multicenter study in Germany Number of centers: Seven centres agreed already to participate in the study. More centers have been and will be contacted.
Design: non-interventional prospective, longitudinal multicenter study Planned number of patients/volunteers: 228 Inclusion criteria: positive S. aureus cultures for more than 6 months within the last year; children (>6 years) and patients with CF, who are able to perform lung function tests Exclusion criteria: Pseudomonas aeruginosa and/or Burkholderia cepacia colonization or infection for more than 6 months within the last year before recruitment; patients who have not been colonized with these pathogens before but acquire them within the study period and are colonized/infected for more than 6 months during the observation period
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Other: non-interventional studyCF-patients with persistent culture of Staphylococcus aureus in their respiratory specimens |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CF-patients with persistent S. aureus culture in their airway specimens
Key inclusion criteria (1 listed)
- positive S. aureus cultures for more than 6 months within the last year; children (>6 years) and patients with CF, who are able to perform lung function tests
Key exclusion criteria (1 listed)
- Pseudomonas aeruginosa and/or Burkholderia cepacia colonization or infection for more than 6 months within the last year before recruitment; patients who have not been colonized with these pathogens before but acquire them within the study period and are colonized/infected for more than 6 months during the observation period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-interventional studyAlso: does not applydoes not apply | Other | Observation |
Primary outcome
bacterial load of sputum cultures [high (>/= 1000000CFU/ml); low (<1000000CFU/ml)]
Time frame: 2 years
1 secondary outcome
antibody titres against S. aureus specific antigens; S100A12, IL-8, TNF-alpha, CRP
Time frame: 2 years
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 7 Jan 2015.
- Derived from this study: PubMed 27861524Junge S, Gorlich D, den Reijer M, Wiedemann B, Tummler B, Ellemunter H, Dubbers A, Kuster P, Ballmann M, Koerner-Rettberg C, Grosse-Onnebrink J, Heuer E, Sextro W, Mainz JG, Hammermann J, Riethmuller J, Graepler-Mainka U, Staab D, Wollschlager B, Szczepanski R, Schuster A, Tegtmeyer FK, Sutharsan S, Wald A, Nofer JR, van Wamel W, Becker K, Peters G, Kahl BC. Factors Associated with Worse Lung Function in Cystic Fibrosis Patients with Persistent Staphylococcus aureus. PLoS One. 2016 Nov 18;11(11):e0166220. doi: 10.1371/journal.pone.0166220. eCollection 2016.
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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
Dept. Med. Microbiology, University Clinics Muenster, Germany
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by University Hospital Muenster at 17 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 7 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
bacterial load of sputum cultures [high (>/= 1000000CFU/ml); low (<1000000CFU/ml)] (time frame: 2 years). 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 NCT00669760, 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 7 Jan 2015.