Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT04700358
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2021-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum and PBMCs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2021-01-06', 'studyFirstSubmitQcDate': '2021-01-06', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of antibacterial antibodies', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Cystic Fibrosis', 'Neutralizing Antibodies']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of the University Hospital Cologne', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Ability to give consent\n* Normal vital signs including:\n* Blood pressure systolic value 150 - 100 mmHg, diastolic value \\< 90 mmHg\n* Respiratory rate \\< 20/min\n* Oxygen saturation \\>92%\n* Heart rate 50 - 110/min\n* Body temperature \\<38°C\n\nExclusion Criteria:\n\n* Cytopenia (leukocytes \\< 1.500/µl, thrombocytes \\< 50.000/µl, Hemoglobin \\< 12 g/dl)\n* Heart disease or pulmonary hypertension\n* Body weight \\<50 kg (exclusion of blood sampling for B cell isolation)\n* Blood donation, larger blood loss and/or major surgery in the last 8 (male) or 12 (female) weeks\n* 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%)'}, 'identificationModule': {'nctId': 'NCT04700358', 'briefTitle': 'Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Cologne'}, 'officialTitle': 'Identification and Characterization of Antibacterial Antibodies in Sera of Patients With Cystic Fibrosis', 'orgStudyIdInfo': {'id': '20-1287_1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Cystic Fibrosis', 'description': 'Patients with pulmonary Cystic Fibrosis with or without bacterial colonization', 'interventionNames': ['Other: Blood sampling']}, {'label': 'Control group', 'description': 'Healthy age- and sex-matched controls including healthy individuals and patients with acute or chronic bacterial infections', 'interventionNames': ['Other: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'OTHER', 'description': 'Screening: Blood sampling of 15 ml whole blood\n\nB 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)', 'armGroupLabels': ['Control group', 'Patients with Cystic Fibrosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Silke van Koningsbruggen-Rietschel, MD, PhD', 'role': 'CONTACT'}, {'name': 'Silke van Koningsbruggen-Rietschel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ernst Rietschel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jan Rybniker, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alexander Simonis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CF Study Center, University Hospital Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'centralContacts': [{'name': 'Alexander Simonis', 'role': 'CONTACT', 'email': 'alexander.simonis@uk-koeln.de', 'phone': '+4922147889608'}], 'overallOfficials': [{'name': 'Silke van Koningsbruggen-Rietschel, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Cologne'}, {'name': 'Jan Rybniker, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Cologne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Alexander Simonis', 'investigatorAffiliation': 'University of Cologne'}}}}