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Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis

Recruitingn/aAges 18 Years - anyAllUniversity Hospital of Cologne
NCT04700358 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, inh

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📋 Eligibility rules (as published)
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%)
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What it tests

  • Blood sampling
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Where

1 site
CF Study Center, University Hospital Cologne
Cologne, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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