Analyzing Antibacterial Antibodies in Cystic Fibrosis Patients
Identification and Characterization of Antibacterial Antibodies in Sera of Patients With Cystic Fibrosis
This study is testing if certain antibodies in the blood of cystic fibrosis patients can help fight off bacteria that cause infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital of Cologne Academic / other |
| Locations | 1 site (Cologne) |
| Trial ID | NCT04700358 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with cystic fibrosis who have experienced bacterial colonization or infections.
Not a fit: Patients with significant heart disease, pulmonary hypertension, or those who have experienced a recent decline in health may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of new therapies that enhance the immune response in cystic fibrosis patients, potentially reducing infection severity and improving lung function.
How similar studies have performed: While the approach of analyzing neutralizing antibodies in cystic fibrosis is promising, it is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cologne
- CF Study Center, University Hospital Cologne — Cologne, Germany (Recruiting)
Study contacts
- Study coordinator: Alexander Simonis
- Email: alexander.simonis@uk-koeln.de
- Phone: +4922147889608
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.