Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00669760
Recruitment Status : Completed
First Posted : April 30, 2008
Last Update Posted : January 7, 2015
Mukoviszidose eV Bonn Germany
Information provided by (Responsible Party):
Barbara Kahl, University Hospital Muenster

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:

  • 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.

Condition or disease Intervention/treatment
Cystic Fibrosis Other: non-interventional study

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 195 participants
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.
Study Start Date : July 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Group/Cohort Intervention/treatment
CF-patients with persistent culture of Staphylococcus aureus in their respiratory specimens
Other: non-interventional study
does not apply
Other Name: does not apply

Primary Outcome Measures :
  1. bacterial load of sputum cultures [high (>/= 1000000CFU/ml); low (<1000000CFU/ml)] [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. antibody titres against S. aureus specific antigens; S100A12, IL-8, TNF-alpha, CRP [ Time Frame: 2 years ]

Biospecimen Retention:   None Retained

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
CF-patients with persistent S. aureus culture in their airway specimens

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00669760

Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
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
University Clinics Muenster
Muenster, Germany, 48149
Muenster, Germany, 48153
Children's Hospital Osnabrueck
Osnabrueck, Germany, 49082
University Clinics Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Muenster
Mukoviszidose eV Bonn Germany
Principal Investigator: Barbara C Kahl, MD Dept. Med. Microbiology, University Clinics Muenster, Germany

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Barbara Kahl, Prof. Dr. Barbara Kahl, University Hospital Muenster Identifier: NCT00669760     History of Changes
Other Study ID Numbers: Muko e.V. S05/07
First Posted: April 30, 2008    Key Record Dates
Last Update Posted: January 7, 2015
Last Verified: January 2015

Keywords provided by Barbara Kahl, University Hospital Muenster:
cystic fibrosis
Staphylococcus aureus
persistent colonization-infection
clinical status
lung function

Additional relevant MeSH terms:
Cystic Fibrosis
Staphylococcal Infections
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Positive Bacterial Infections
Bacterial Infections