NCT04700358Recruiting
Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis
Identification and Characterization of Antibacterial Antibodies in Sera of Patients With Cystic Fibrosis
Source: ClinicalTrials.gov · Last updated 8 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 75 (estimated)
- First submitted
- 6 Jan 2021
- Start date
- 1 Oct 2020
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- University Hospital of Cologne
- Diseases
- Cystic fibrosis
- NCT number
- NCT04700358
What you commit to
- Study type: Observational
- Planned participants: 75
- From 1 Oct 2020 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Blood donation, larger blood loss and/or major surgery in the last 8 (male) or 12 (female) weeks
Other illness
- Heart disease or pulmonary hypertension
- 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%)
Lab values
- Cytopenia (leukocytes \< 1.500/µl, thrombocytes \< 50.000/µl, Hemoglobin \< 12 g/dl)
Other
- Body weight \<50 kg (exclusion of blood sampling for B cell isolation)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CF Study Center, University Hospital Cologne Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.