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| Sponsor: | University Hospital Muenster |
|---|---|
| Collaborator: |
Mukoviszidose eV Bonn Germany |
| Information provided by: | University Hospital Muenster |
| ClinicalTrials.gov Identifier: | NCT00669760 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cystic Fibrosis |
Other: non-interventional study |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients, a Non-interventional, Prospective, Longitudinal Multicenter Study. |
Sera
| Estimated Enrollment: | 193 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Observation
CF-patients with persistent culture of Staphylococcus aureus in their respiratory specimens
|
Other: non-interventional study
does not apply
Other Name: does not apply
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 6 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
CF-patients with persistent S. aureus culture in their airway specimens
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Austria | |
| Medizinische Universität Innsbruck | |
| Innsbruck, Austria, 6020 | |
| Germany | |
| Charite Berlin Campus Benjamin Franklin | |
| Berlin, Germany, 12200 | |
| Clinic for Children and Adolescents Ruhr University Bochum St Josef Hospital | |
| Bochum, Germany, 44791 | |
| Universitätsklinikum Carl Gustav Carus | |
| Dresden, Germany, 01307 | |
| Heinrich-Heine University Duesseldorf | |
| Duesseldorf, Germany, 40225 | |
| University Clinics Essen | |
| Essen, Germany, 45122 | |
| Ruhrlandklinik Essen-Heidhausen | |
| Essen, Germany, 45239 | |
| Universitätsklinikum Halle | |
| Halle, Germany, 06120 | |
| Dres Heuer-Runge-Sextro | |
| Hamburg, Germany, 22763 | |
| Medical School Hannover | |
| Hannover, Germany, 30625 | |
| University Clinics Jena | |
| Jena, Germany, 07743 | |
| Children's Hospital Park Schoenfeld | |
| Kassel, Germany, 34121 | |
| Universitätsklinikum Leipzig | |
| Leipzig, Germany, 04103 | |
| Clemenshospital | |
| Muenster, Germany, 48153 | |
| University Clinics Muenster | |
| Muenster, Germany, 48149 | |
| Children's Hospital Osnabrueck | |
| Osnabrueck, Germany, 49082 | |
| University Clinics Tuebingen | |
| Tuebingen, Germany, 72076 | |
| Principal Investigator: | Barbara C Kahl, MD | Dept. Med. Microbiology, University Clinics Muenster, Germany |
More Information
| Responsible Party: | Dr. Barbara C. Kahl, Dept. of Med. Microbiology, University Clinics Muenster, Germany |
| ClinicalTrials.gov Identifier: | NCT00669760 History of Changes |
| Other Study ID Numbers: | Muko e.V. S05/07 |
| Study First Received: | April 28, 2008 |
| Last Updated: | August 3, 2011 |
| Health Authority: | Germany: Federal Ministry of Education and Research |
|
cystic fibrosis Staphylococcus aureus persistent colonization-infection clinical status lung function |
|
Cystic Fibrosis Fibrosis Pancreatic Diseases Digestive System Diseases Lung Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes |