Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital of Cologne

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18 years

Ability to give consent

Blood pressure systolic value 150 - 100 mmHg, diastolic value < 90 mmHg

Respiratory rate < 20/min

Disqualifiers

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

Trial population

Patients of the University Hospital Cologne

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • Blood sampling

    Other intervention

    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)

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Patients with Cystic Fibrosis1 intervention
Group B: Control group1 intervention

Trial outcomes

Primary outcomes

1

Prevalence of antibacterial antibodies

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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University Hospital of Cologne

Lead sponsor

University of Cologne

Sponsor institution