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Most of the cystic fibrosis (CF) patients are or have been pulmonary colonized with bacteria such as Pseudomonas aeruginosa or Staphylococcus aureus. Aim of this study is to detect virulence factor neutralizing antibodies in the sera of the study population followed by B cell repertoire analyses to design B cell-derived neutralizing monoclonal antibodies. The functionality of neutralizing antibodies rests on inhibition of virulence factors by binding of crucial epitopes rather than merely the induction of opsonization. Focusing on patients with bacterial colonization/chronic infections or a history of an acute infection in the past, will increase the likelihood for identification of serum with neutralizing activity as in vivo antigen contact is a prerequisite for antibody development and maturation. Since virulence factors are essential for infection, dissemination and tissue damage, inhibition of these factors by developed neutralizing antibodies might contribute to a favorable outcome of life-threatening infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Cystic Fibrosis | Patients with pulmonary Cystic Fibrosis with or without bacterial colonization |
| |
| Control group | Healthy age- and sex-matched controls including healthy individuals and patients with acute or chronic bacterial infections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Other | Screening: Blood sampling of 15 ml whole blood B cell isolation: Blood sampling of max. 400 ml whole blood or 6% of the total blood volume (♀ 65 ∓ 10 ml/kg; ♂ 77 ∓ 10 ml/kg) |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of antibacterial antibodies | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients of the University Hospital Cologne
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Simonis | Contact | +4922147889608 | alexander.simonis@uk-koeln.de |
| Name | Affiliation | Role |
|---|---|---|
| Silke van Koningsbruggen-Rietschel, MD, PhD | University Hospital Cologne | Study Director |
| Jan Rybniker, MD, PhD | University Hospital Cologne | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CF Study Center, University Hospital Cologne | Recruiting | Cologne | Germany |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Serum and PBMCs
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |