Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients

Cystic Fibrosis Clinical Trial

— StaphCI  

Official title:

Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients, a Non-interventional, Prospective, Longitudinal Multicenter Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669760
• Other study ID #: Muko e.V. S05/07
• Status: Completed
• Phase: N/A
• First received: April 28, 2008
• Last updated: January 6, 2015
• Start date: July 2008
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Observational

Clinical Trial 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.

Description:

Protocol synopsis Title: Dissection of Staphylococcus aureus infection from colonization in cystic fibrosis patients. A non-interventional prospective, 2-year longitudinal multicenter study

Study objectives: The aim of the study is to dissect S. aureus infection from colonization of the pathogen in airway secretions of CF patients during a 2 year period by means of a non-interventional, prospective, longitudinal multicenter study.

The following hypothesis will be developed:

CF patients with high bacterial loads are more likely to be infected by S. aureus than patients with low bacterial loads.

Definition of infection:

• change in volume, colour or consistency of sputum (exacerbation)

• increased cough

• malaise, fatigue or lethargy

• body temperature more than 38°C

• new or increased hemoptysis

• anorexia or weight loss

• sinus pain or tenderness

• change in sinus discharge

• change in chest sounds

• ten percent decrease in pulmonary function from a previous recorded value (FEV1, MEF25)

• radiographic changes indicative of pulmonary infection

Primary endpoint: bacterial load of sputum cultures [high (>/= 106CFU/ml); low (<106CFU/ml)]

Secondary endpoints are:

• assessment of nasal S. aureus carriage

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

• molecular analysis of S. aureus colonization/infection (monoclonal or heteroclonal)

• sputa analysis: activity of S100A12, IL-8 and myeloperoxidase

• antibiotic treatment regimens against S. aureus

• body mass index

• lung function tests: FEV1, deltaFVC, deltaMEF25

Extensive microbiological investigations will be performed when the patients are seen at their regular visits in the outpatient clinics or if exacerbations occur. During the study period of 2 years, at least 8 visits to the outpatient clinic should be recorded. The following clinical parameters will be documented:

• lung function

• body mass index (weight/height)

• antibiotic treatment Diagnosis: CF and positive S. aureus cultures for more than 6 months within the last year Localisation of the study: multicenter study in Germany Number of centers: Seven centres agreed already to participate in the study. More centers have been and will be contacted.

Design: non-interventional prospective, longitudinal multicenter study Planned number of patients/volunteers: 228 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: January 2015
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• non-interventional study
does not apply

Locations

Country	Name	City	State
Austria	Medizinische Universität Innsbruck	Innsbruck
Germany	Charite Berlin Campus Benjamin Franklin	Berlin
Germany	Clinic for Children and Adolescents Ruhr University Bochum St Josef Hospital	Bochum
Germany	Universitätsklinikum Carl Gustav Carus	Dresden
Germany	Heinrich-Heine University Duesseldorf	Duesseldorf
Germany	Ruhrlandklinik Essen-Heidhausen	Essen
Germany	University Clinics Essen	Essen
Germany	Universitätsklinikum Halle	Halle
Germany	Dres Heuer-Runge-Sextro	Hamburg
Germany	Medical School Hannover	Hannover
Germany	University Clinics Jena	Jena
Germany	Children's Hospital Park Schoenfeld	Kassel
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Clemenshospital	Muenster
Germany	University Clinics Muenster	Muenster
Germany	Children's Hospital Osnabrueck	Osnabrueck
Germany	University Clinics Tuebingen	Tuebingen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	Mukoviszidose eV Bonn Germany

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bacterial load of sputum cultures [high (>/= 1000000CFU/ml); low (<1000000CFU/ml)]		2 years	No
Secondary	antibody titres against S. aureus specific antigens; S100A12, IL-8, TNF-alpha, CRP		2 years	No

External Links

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