Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI)
Tracking Information | |||||
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First Received Date ICMJE | April 28, 2008 | ||||
Last Updated Date | August 3, 2011 | ||||
Start Date ICMJE | July 2008 | ||||
Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
bacterial load of sputum cultures [high (>/= 1000000CFU/ml); low (<1000000CFU/ml)] [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00669760 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
antibody titres against S. aureus specific antigens; S100A12, IL-8, TNF-alpha, CRP [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients | ||||
Official Title ICMJE | Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients, a Non-interventional, Prospective, Longitudinal Multicenter Study. | ||||
Brief 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. 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:
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. |
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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:
Primary endpoint: bacterial load of sputum cultures [high (>/= 106CFU/ml); low (<106CFU/ml)] Secondary endpoints are:
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:
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 |
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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Biospecimen | Retention: None Retained Description: Sera |
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Sampling Method | Probability Sample | ||||
Study Population | CF-patients with persistent S. aureus culture in their airway specimens |
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Condition ICMJE | Cystic Fibrosis | ||||
Intervention ICMJE | Other: non-interventional study
does not apply
Other Name: does not apply |
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Study Group/Cohort (s) | Observation
CF-patients with persistent culture of Staphylococcus aureus in their respiratory specimens
Intervention: Other: non-interventional study |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 193 | ||||
Estimated Completion Date | December 2011 | ||||
Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 6 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Austria, Germany | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00669760 | ||||
Other Study ID Numbers ICMJE | Muko e.V. S05/07 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Dr. Barbara C. Kahl, Dept. of Med. Microbiology, University Clinics Muenster, Germany | ||||
Study Sponsor ICMJE | University Hospital Muenster | ||||
Collaborators ICMJE | Mukoviszidose eV Bonn Germany | ||||
Investigators ICMJE |
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Information Provided By | University Hospital Muenster | ||||
Verification Date | August 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |