Status:
RECRUITING
Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis
Lead Sponsor:
University Hospital of Cologne
Conditions:
Pulmonary Cystic Fibrosis
Neutralizing Antibodies
Eligibility:
All Genders
18+ years
Brief Summary
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 ne...
Eligibility Criteria
Inclusion
- 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°C
Exclusion
- Cytopenia (leukocytes \< 1.500/µl, thrombocytes \< 50.000/µl, 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%)
Key Trial Info
Start Date :
October 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04700358
Start Date
October 1 2020
End Date
December 31 2027
Last Update
May 8 2024
Active Locations (1)
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1
CF Study Center, University Hospital Cologne
Cologne, Germany