NCT04700358

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Oct 2020Dec 2027

Study Start

First participant enrolled

October 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

7 years

First QC Date

January 6, 2021

Last Update Submit

May 7, 2024

Conditions

Pulmonary Cystic FibrosisNeutralizing Antibodies

Outcome Measures

Primary Outcomes (1)

  • Prevalence of antibacterial antibodies

    3 years

Study Arms (2)

Patients with Cystic Fibrosis

Patients with pulmonary Cystic Fibrosis with or without bacterial colonization

Other: Blood sampling

Control group

Healthy age- and sex-matched controls including healthy individuals and patients with acute or chronic bacterial infections

Other: Blood sampling

Interventions

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)

Control groupPatients with Cystic Fibrosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of the University Hospital Cologne

You may qualify if:

  • 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

You may not qualify if:

  • Cytopenia (leukocytes \< 1.500/µl, thrombocytes \< 50.000/µl, Hemoglobin \< 12 g/dl)
  • Heart disease or pulmonary hypertension
  • 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%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CF Study Center, University Hospital Cologne

Cologne, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum and PBMCs

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Silke van Koningsbruggen-Rietschel, MD, PhD

    University Hospital Cologne

    STUDY DIRECTOR

  • Jan Rybniker, MD, PhD

    University Hospital Cologne

    STUDY DIRECTOR

Central Study Contacts

Alexander Simonis

CONTACT

+4922147889608alexander.simonis@uk-koeln.de

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 7, 2021

Study Start

October 1, 2020

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations

DE(1)