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RECRUITINGOBSERVATIONAL

Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis

Identification and Characterization of Antibacterial Antibodies in Sera of Patients With Cystic Fibrosis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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%) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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%)

Treatments Being Tested

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)

Locations (1)

CF Study Center, University Hospital Cologne
Cologne, Germany