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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00669760 |
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Date of registration:
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28/04/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients
StaphCI |
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Scientific title:
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Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients, a Non-interventional, Prospective, Longitudinal Multicenter Study. |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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195 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00669760 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Austria
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Germany
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Contacts
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Name:
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Barbara C Kahl, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dept. Med. Microbiology, University Clinics Muenster, Germany |
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Other: non-interventional study
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Primary Outcome(s)
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bacterial load of sputum cultures [high (>/= 1000000CFU/ml); low (<1000000CFU/ml)]
[Time Frame: 2 years]
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Secondary Outcome(s)
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antibody titres against S. aureus specific antigens; S100A12, IL-8, TNF-alpha, CRP
[Time Frame: 2 years]
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Secondary ID(s)
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Muko e.V. S05/07
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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