Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis

Pulmonary Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04700358
• Other study ID #: 20-1287_1
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: University Hospital of Cologne
• Contact: Alexander Simonis
• Phone: +4922147889608
• Email: alexander.simonis[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2027
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Neutralizing Antibodies
• Pulmonary Cystic Fibrosis

Intervention

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

Country	Name	City	State
Germany	CF Study Center, University Hospital Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of antibacterial antibodies		3 years