Actively Recruiting
Identification and Characterization of Antibacterial Antibodies in Sera of Patients With Cystic Fibrosis
Led by University Hospital of Cologne · Updated on 2024-05-08
75
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with pulmonary cystic fibrosis (CF), focusing on those who have or have had lung colonization or infections by bacteria like Pseudomonas aeruginosa or Staphylococcus aureus. The study aims to detect antibodies in the blood that can neutralize bacterial virulence factors, which play a key role in infection and tissue damage. By analyzing these antibodies and related B cells, researchers hope to develop specialized monoclonal antibodies that can better target these harmful factors. Participants include those with CF, whether or not they currently have bacterial colonization, as well as healthy people matched by age and sex, including some with acute or chronic bacterial infections. The study involves blood sampling, starting with 15 ml of whole blood for screening, and up to 400 ml for B cell isolation. Blood collection is done carefully considering total blood volume based on body weight and sex. During the study, participants will have blood drawn to analyze the presence and function of antibacterial antibodies. Researchers will monitor vital signs like blood pressure, oxygen levels, heart rate, and temperature to ensure safety. The main outcome is to measure how common these antibacterial antibodies are over three years. Participation involves blood tests and health monitoring, with study activities designed to safely collect the information needed to understand antibody responses in CF.
CONDITIONS
Brief Title
Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability to give consent
- Normal vital signs including:
- Blood pressure systolic value 100 to 150 mmHg, diastolic value less than 90 mmHg
- Respiratory rate less than 20 per minute
- Oxygen saturation greater than 92%
- Heart rate between 50 and 110 per minute
- Body temperature less than 38 degrees Celsius
You will not qualify if you...
- Cytopenia defined as leukocytes less than 1,500/µl, thrombocytes less than 50,000/µl, or hemoglobin less than 12 g/dl
- History of heart disease or pulmonary hypertension
- Body weight less than 50 kg (excludes blood sampling for B cell isolation)
- Blood donation, major blood loss, or major surgery within the last 8 weeks for males or 12 weeks for females
- Any decline in general health in the last 3 months including weight loss over 2 kg, pulmonary exacerbation, or increased lung function impairment with FEV1 less than 50%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants provide blood samples to characterize antibacterial antibodies.
1 to 2 visits depending on cohort and sampling requirements
Trial Site Locations
Total: 1 location
1
CF Study Center, University Hospital Cologne
Cologne, Germany
Actively Recruiting
Research Team
A
Alexander Simonis
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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