Characterization of Antibacterial Antibodies in 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.

Full Title of Study: “Identification and Characterization of Antibacterial Antibodies in Sera of Patients With Cystic Fibrosis”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: September 30, 2023

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)

Arms, Groups and Cohorts

  • Patients with Cystic Fibrosis
    • Patients with pulmonary Cystic Fibrosis with or without bacterial colonization
  • Control group
    • Healthy age- and sex-matched controls including healthy individuals and patients with acute or chronic bacterial infections

Clinical Trial Outcome Measures

Primary Measures

  • Prevalence of antibacterial antibodies
    • Time Frame: 3 years

Participating in This Clinical Trial

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%)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital of Cologne
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alexander Simonis, MD – University of Cologne
  • Overall Official(s)
    • Silke van Koningsbruggen-Rietschel, MD, PhD, Study Director, University Hospital Cologne
    • Jan Rybniker, MD, PhD, Study Director, University Hospital Cologne
  • Overall Contact(s)
    • Alexander Simonis, +4922147889608, alexander.simonis@uk-koeln.de

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