Studying Antibodies Against Bacteria in People With Cystic Fibrosis
Studies blood samples from people with cystic fibrosis to find antibodies that block bacterial harm.
Plain-language title generated from the registry record
Registry title: Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis
Key facts
- Where
- Cologne, GermanySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with cystic fibrosis who can give consent and have normal vital signs. Blood samples will be taken to study antibodies against bacteria.
- Age
- 18 years or older
- Sex
- All sexes can join.
Main reasons for not taking part
- Low blood counts (leukocytes < 1.500/µl, thrombocytes < 50.000/µl, hemoglobin < 12 g/dl)
- Heart disease or pulmonary hypertension
- Body weight < 50 kg (110 lb)
- Blood donation, larger blood loss or major surgery in the last 8 weeks (men) or 12 weeks (women)
- Worse general health in the last 3 months, such as weight loss > 2kg (4 lb (2 kg)), pulmonal exacerbation or lung function FEV1 < 50%
Read by machine on 9 November 2026.
Where in Germany
- CF Study Center, University Hospital CologneCologne, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital of Cologne
- Trial code
- NCT04700358
- Record updated
- 8 May 2024
- Original description
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.Read full original descriptionShow less
Identification and Characterization of Antibacterial Antibodies in Sera of Patients With Cystic Fibrosis
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.
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: Blood donation, larger blood loss and/or major surgery in the last 8 (male) or 12 (female) weeks; Heart disease or pulmonary hypertension; 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%); Cytopenia (leukocytes < 1.500/µl, thrombocytes < 50.000/µl, Hemoglobin < 12 g/dl); Body weight <50 kg (exclusion of blood sampling for B cell isolation).