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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University Hospital Muenster.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Mukoviszidose eV Bonn Germany
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00669760
First received: April 28, 2008
Last updated: August 3, 2011
Last verified: August 2011
  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:

  • 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 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.

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • bacterial load of sputum cultures [high (>/= 1000000CFU/ml); low (<1000000CFU/ml)] [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • antibody titres against S. aureus specific antigens; S100A12, IL-8, TNF-alpha, CRP [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

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
Study Population

CF-patients with persistent S. aureus culture in their airway specimens

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669760

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
Sponsors and Collaborators
University Hospital Muenster
Mukoviszidose eV Bonn Germany
Investigators
Principal Investigator: Barbara C Kahl, MD Dept. Med. Microbiology, University Clinics Muenster, Germany
  More Information

Additional Information:
No publications provided

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

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

Additional relevant MeSH terms:
Infection
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on October 01, 2014