History of Changes for Study: NCT00669760

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

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Study Record Versions

Version	Submitted Date	Changes
1	April 29, 2008	None (earliest Version on record)
2	June 6, 2008	Sponsor/Collaborators and Study Status
3	July 4, 2008	Recruitment Status, Contacts/Locations and Study Status
4	August 6, 2008	Contacts/Locations, Sponsor/Collaborators and Study Status
5	December 8, 2008	Contacts/Locations and Study Status
6	August 3, 2011	Recruitment Status, Contacts/Locations, Study Status, Study Design and Study Identification
7	January 6, 2015	Recruitment Status, Study Status, Sponsor/Collaborators and Study Design

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Merged
Side-by-Side

Study Identification


Unique Protocol ID:	Muko e.V. S05/07
Brief Title:	Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI)
Official Title:	Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients, a Non-Interventional, Prospective, Longitudinal Multicenter Study.
Secondary IDs:

Study Status


Record Verification:	April 2008
Overall Status:	Not yet recruiting
Study Start:	June 2008
Primary Completion:	May 2010 [Anticipated]
Study Completion:	May 2010 [Anticipated]

First Submitted:	April 28, 2008
First Submitted that Met QC Criteria:	April 29, 2008
First Posted:	April 30, 2008 [Estimate]

Last Update Submitted that Met QC Criteria:	June 6, 2008
Last Update Posted:	June 9, 2008 [Estimate]

Sponsor/Collaborators


Sponsor:	University Hospital Muenster
Responsible Party:
Collaborators:	University Hospital, Essen Ruhrlandklinik, Essen, Germany University Hospital, Düsseldorf, Germany Hannover Medical School Technische Universität Dresden

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	No

Study Description

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.

Detailed 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

Conditions


Conditions:	Cystic Fibrosis
Keywords:	cystic fibrosis Staphylococcus aureus persistent colonization-infection clinical status lung function

Study Design


Study Type:	Observational
Observational Study Model:	Case-Only
Time Perspective:	Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	248 [Anticipated]
Number of Groups/Cohorts	1

Groups and Interventions

Groups/Cohorts	Interventions
Observation CF-patients with persistent culture of Staphylococcus aureus in their respiratory specimens	non-interventional study does not apply Other Names: does not apply

Outcome Measures


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 ]

Eligibility


Study Population:	CF-patients with persistent S. aureus culture in their airway specimens
Sampling Method:	Probability Sample
Minimum Age:	6 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
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/Locations


Central Contact Person:	Barbara C Kahl, MD Telephone: 49-251-835-5381 Email: kahl@uni-muenster.de
Study Officials:	Barbara C Kahl, MD Principal Investigator Dept. Med. Microbiology, University Clinics Muenster, Germany
Locations:	Germany
	Dr. Thomas Nüsslein Bochum, Germany, 44791 Contact:Contact: Thomas Nüsslein, MD 49-234-509-2680 t.nuesslein@klinikum-bochum.de
	Dr. Bärbel Wiedemann Dresden, Germany, 01069
	Prof. Antje Schuster Düsseldorf, Germany, 40225 Contact:Contact: Antje Schuster, MD 49-211-811-8297 Schuster@med.uni-duesseldorf.de
	Dr. Uwe Mellies Essen, Germany, 45122 Contact:Contact: Uwe Mellies, MD 49-201-723-3355 Uwe.Mellies@uk-essen.de
	Prof. Helmut Teschler Essen, Germany, 45239 Contact:Contact: Helmut Teschler, MD 49-201-937-0 teschlerh@t-online.de
	Dr. Manfred Ballmann Hannover, Germany, 30625
	Dr. Barbara C. Kahl Muenster, Germany, 48149 Contact:Contact: Gabriele Dr. Lubritz, MD 49-251-835-5381 lubritz@uni-muenster.de Contact:Sub-Investigator: Johannes Haeberle, MD Contact:Sub-Investigator: Helmut Wittkowski, MD
	Dr. Peter Kuester Muenster, Germany, 48153

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