Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sampling.
- Who it may be relevant to
- Registry conditions: Pulmonary Cystic Fibrosis, Neutralizing Antibodies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Identification and Characterization of Antibacterial Antibodies in Sera of Patients With Cystic Fibrosis
Overview
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.
Interventions
- Other Blood sampling
Screening: Blood sampling of 15 ml whole blood B cell isolation: Blood sampling of max. 400 ml whole blood or 6% of the total blood volume (♀ 65 ∓ 10 ml/kg; ♂ 77 ∓ 10 ml/kg)
Primary outcome measures
- Prevalence of antibacterial antibodies [Time frame: 3 years]
Eligibility criteria
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%)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Germany · 1 center
- CF Study Center, University Hospital Cologne — Cologne
Identifiers
NCT: NCT04700358 · 20-1287_1