Analyzing Antibacterial Antibodies in Cystic Fibrosis Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify neutralizing antibodies against bacterial virulence factors in patients with cystic fibrosis who are either chronically infected or have a history of acute infections. By analyzing blood samples, researchers will assess the presence of these antibodies and conduct B cell repertoire analyses to develop monoclonal antibodies that can inhibit bacterial virulence. The focus on patients with bacterial colonization increases the likelihood of finding effective neutralizing antibodies, which could lead to improved treatment outcomes.

Why it matters

Who can join: the full rules

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%)

Where it's running

• CF Study Center, University Hospital Cologne
  Cologne, Germany Recruiting

Study contacts

• Study coordinator: Alexander Simonis
• Email: alexander.simonis@uk-koeln.de
• Phone: +4922147889608

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.