Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients

NCT00669760 | Completed

• 1 other identifier: Muko e.V. S05/07
• Study Type: observational
• Target: 195
• Locations: 2 countries
• Sites: 17

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.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; Staphylococcus aureus; persistent colonization-infection; clinical status; lung function

Outcome Measures

Primary Outcomes (1)

• bacterial load of sputum cultures [high (>/= 1000000CFU/ml); low (<1000000CFU/ml)]

  2 years

Secondary Outcomes (1)

• antibody titres against S. aureus specific antigens; S100A12, IL-8, TNF-alpha, CRP

  2 years

Study Arms (1)

Observation

CF-patients with persistent culture of Staphylococcus aureus in their respiratory specimens

Other: non-interventional study

Interventions

non-interventional study OTHER

does not apply

Also known as: does not apply

Observation

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead
• Mukoviszidose eV Bonn Germany: collaborator

Study Sites (17)

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

Location

Charite Berlin Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Clinic for Children and Adolescents Ruhr University Bochum St Josef Hospital

Bochum, 44791, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Heinrich-Heine University Duesseldorf

Düsseldorf, 40225, Germany

Location

University Clinics Essen

Essen, 45122, Germany

Location

Ruhrlandklinik Essen-Heidhausen

Essen, 45239, Germany

Location

Universitätsklinikum Halle

Halle, 06120, Germany

Location

Dres Heuer-Runge-Sextro

Hamburg, 22763, Germany

Location

Medical School Hannover

Hanover, 30625, Germany

Location

University Clinics Jena

Jena, 07743, Germany

Location

Children's Hospital Park Schoenfeld

Kassel, 34121, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

University Clinics Muenster

Münster, 48149, Germany

Location

Clemenshospital

Münster, 48153, Germany

Location

Children's Hospital Osnabrueck

Osnabrück, 49082, Germany

Location

University Clinics Tuebingen

Tübingen, 72076, Germany

Location

Related Publications (1)

• Junge S, Gorlich D, den Reijer M, Wiedemann B, Tummler B, Ellemunter H, Dubbers A, Kuster P, Ballmann M, Koerner-Rettberg C, Grosse-Onnebrink J, Heuer E, Sextro W, Mainz JG, Hammermann J, Riethmuller J, Graepler-Mainka U, Staab D, Wollschlager B, Szczepanski R, Schuster A, Tegtmeyer FK, Sutharsan S, Wald A, Nofer JR, van Wamel W, Becker K, Peters G, Kahl BC. Factors Associated with Worse Lung Function in Cystic Fibrosis Patients with Persistent Staphylococcus aureus. PLoS One. 2016 Nov 18;11(11):e0166220. doi: 10.1371/journal.pone.0166220. eCollection 2016.

  PMID: 27861524 DERIVED

Biospecimen

Retention: NONE RETAINED

Sera

MeSH Terms

Conditions

Cystic Fibrosis; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Barbara C Kahl, MD

  Dept. Med. Microbiology, University Clinics Muenster, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Barbara Kahl

Study Record Dates

• First Submitted: April 28, 2008
• First Posted: April 30, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: January 1, 2015
• Last Updated: January 7, 2015

Record last verified: 2015-01

Locations

DE (16); AU (1)