Pulmonary Cystic FibrosisNCT04700358
Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis
An observational study of Pulmonary Cystic Fibrosis and Neutralizing Antibodies, run by University Hospital of Cologne at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Cystic Fibrosis, Neutralizing Antibodies
- What is being tested?
- Blood sampling
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2020to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of the University Hospital Cologne
Who may be able to join
- 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 cannot join
- 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%)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
CF Study Center, University Hospital Cologne
Cologne
Silke van Koningsbruggen-Rietschel, MD, PhD
Silke van Koningsbruggen-Rietschel, MD, PhD
About this study
Official title: Identification and Characterization of Antibacterial Antibodies in Sera of Patients With Cystic Fibrosis
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.
- Conditions
- Pulmonary Cystic Fibrosis, Neutralizing Antibodies
- Being tested
- Blood sampling
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Patients with Cystic Fibrosis | Patients with pulmonary Cystic Fibrosis with or without bacterial colonization Receives: Other: Blood sampling | |
| Control group | Healthy age- and sex-matched controls including healthy individuals and patients with acute or chronic bacterial infections Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of antibacterial antibodies
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start1 Oct 2020
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Simonis, University of Cologne
- Investigators
- Silke van Koningsbruggen-Rietschel, MD, PhD, Study director, University Hospital of CologneJan Rybniker, MD, PhD, Study director, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700358
- Sponsor's protocol ID
- 20-1287_1
- Status last verified
- May 2024
- First submitted
- 6 Jan 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Characterization of Antibacterial Antibodies in Sera of Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04700358
- Acronym / sponsor ID
- 20-1287_1
- Conditions
- Pulmonary Cystic Fibrosis, Neutralizing Antibodies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Cystic Fibrosis | – | Other: Blood samplingPatients with pulmonary Cystic Fibrosis with or without bacterial colonization |
| Control group | – | Other: Blood samplingHealthy age- and sex-matched controls including healthy individuals and patients with acute or chronic bacterial infections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the University Hospital Cologne
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingScreening: 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) | Other | Control group, Patients with Cystic Fibrosis |
Primary outcome
Prevalence of antibacterial antibodies
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silke van Koningsbruggen-Rietschel, MD, PhD study director
University Hospital of Cologne
Jan Rybniker, MD, PhD study director
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Cystic Fibrosis and Neutralizing Antibodies, run by University Hospital of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Simonis (+4922147889608, alexander.simonis@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of antibacterial antibodies (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.