Isolation of Human Recombinant Therapeutic Monoclonal Anti-Pseudomonas Antibodies

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pseudomonas Aeruginosa, Multi-antibiotic Resistance

Intervention / Treatment
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* Biological: Isolation of anti-Pseudomonas antibodies from type B lymphocytes


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isolation of recombinant human monoclonal antibodies against Pseudomonas aeruginosa | Detection of binding of recombinant antibodies to Pseudomonas aeruginosa target proteins by ELISA assay. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isolation of functional antibodies against Pseudomonas aeruginosa | Percentage of inhibition of Pseudomonas aeruginosa infection by antibodies using an in vitro model of cell infection and virulence. Percentage of lysis of Pseudomonas aeruginosa in the presence of recombinant IgG, complement and macrophages in an opsonophagocytosis assay | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pseudomonas aeruginosa, monoclonal antibody