Isolation of Human Recombinant Therapeutic Monoclonal Anti-Pseudomonas Antibodies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Legally protected patient (minor, pregnant or nursing woman, ward or ward curated, hospitalized under duress or deprived of liberty)
Trial population
Patient previously infected or colonized by Pseudomonas aeruginosa with serum containing functional anti-Pseudomonas aeruginosa antibodies
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Isolation of anti-Pseudomonas antibodies from type B lymphocytes
Biological/VaccineBlood 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Isolation of recombinant human monoclonal antibodies against Pseudomonas aeruginosa
Detection of binding of recombinant antibodies to Pseudomonas aeruginosa target proteins by ELISA assay.
Time frame
1 daySecondary outcomes
1
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
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov