Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis

University Hospital of Cologne

Status

Enrolling

Conditions

Pulmonary Cystic Fibrosis

Neutralizing Antibodies

Treatments

Other: Blood sampling

Study type

Observational

Funder types

Other

Identifiers

NCT04700358

20-1287_1

Details and patient eligibility

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.

Enrollment

75 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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%)