Actively Recruiting
Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis
Led by University Hospital of Cologne · Updated on 2024-05-08
75
Participants Needed
1
Research Sites
378 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years
- Ability to give consent
- Normal vital signs including:
- Blood pressure systolic value 150 - 100 mmHg, diastolic value < 90 mmHg
- Respiratory rate < 20/min
- Oxygen saturation >92%
- Heart rate 50 - 110/min
- Body temperature <38�b0C
You will not qualify if you...
- Cytopenia (leukocytes < 1.500/�b5l, thrombocytes < 50.000/�b5l, Hemoglobin < 12 g/dl)
- Heart disease or pulmonary hypertension
- Body weight <50 kg (exclusion of blood sampling for B cell isolation)
- Blood donation, larger blood loss and/or major surgery in the last 8 (male) or 12 (female) weeks
- Any decline of the general state of health in the last 3 month including weight loss > 2kg, pulmonal exacerbation or increased impairment of pulmonary function (FEV1 < 50%)
AI-Screening
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Trial Site Locations
Total: 1 location
1
CF Study Center, University Hospital Cologne
Cologne, Germany
Actively Recruiting
Research Team
A
Alexander Simonis
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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