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Clinical trial

Isolation of Human Recombinant Therapeutic Monoclonal Anti-Pseudomonas Antibodies From B Lymphocytes of Patients Who Have Been Followed for Infection or Colonization With Pseudomonas Aeruginosa: a Prospective Monocentric Trial

ID
Name
38RC20.048
Description
Pseudomonas aeruginosa is a pathogenic bacteria for human, especially in hospital settings. It can sometimes be multi-resistant to many or even to all antibiotics usually used for its treatment. The aim of the study is to isolate and produce therapeutic antibodies against the bacteria Pseudomonas aeruginosa in order to provide an alternative treatment to antibiotics in case of infection with an antibiotic-resistant strain of Pseudomonas aeruginosa.
Trial arms
Trial start
2020-10-05
Estimated PCD
2025-10-01
Trial end
2025-10-01
Status
Recruiting
Treatment
Isolation of anti-Pseudomonas antibodies from type B lymphocytes
Blood sampling. Isolation of mononuclear cells from human peripheral blood by density gradient centrifugation. Identification of functional anti-Pseudomonas antibodies by ELISA and cellular infection assays.
Size
10
Primary endpoint
Isolation of recombinant human monoclonal antibodies against Pseudomonas aeruginosa
1 day
Eligibility criteria
Inclusion Criteria: * Patient selected in the retrospective part of the study (patient with serum containing functional anti-Pseudomonas aeruginosa antibodies) * Patient with weight ≥ 32kg. * With a follow-up visit at Grenoble University Hospital with a blood sampling for its care * Having given its written no objection to participate in the prospective phase of this project Exclusion Criteria: * Legally protected patient (minor, pregnant or nursing woman, ward or ward curated, hospitalized under duress or deprived of liberty)
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample'}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}
Updated at
2023-08-07

1 organization

1 product

2 indications

Organization
University Hospital of Grenoble
Product
Isolation of anti-Pseudomonas antibodies
Indication
Pseudomonas aeruginosa
Indication
Multi-antibiotic Resistance