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NCT Number: NCT04700358

Characterization of Antibacterial Antibodies in 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.

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Key information

Conditions

Pulmonary Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Neutralizing Antibodies Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CF Study Center, University Hospital Cologne

Cologne, Germany

Location status: Recruiting

Location contact

Alexander Simonis, MD

PRINCIPAL_INVESTIGATOR

Ernst Rietschel, MD

PRINCIPAL_INVESTIGATOR

Jan Rybniker, MD, PhD

PRINCIPAL_INVESTIGATOR

Silke van Koningsbruggen-Rietschel, MD, PhD

CONTACT

Silke van Koningsbruggen-Rietschel, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Blood sampling

Other

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)

Primary outcomes

Prevalence of antibacterial antibodies

Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Simonis

CONTACT

[email protected]

+4922147889608

Sponsors and collaborators

Lead sponsor

University Hospital of Cologne

Other

Registry information

Official study title

Identification and Characterization of Antibacterial Antibodies in Sera of Patients With Cystic Fibrosis

Important dates

Study start: 2020
Primary completion: 2027
Study completion: 2027
First posted: Jan 7, 2021
Registry last updated: May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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