Clinical trial NCT04335383: Isolation of Human Recombinant Therapeutic Monoclonal Anti-Pseudomonas Antibodies
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pseudomonas Aeruginosa
Multi-antibiotic Resistance
Keywords: Pseudomonas aeruginosa
monoclonal antibody
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient previously infected or colonized by Pseudomonas aeruginosa with serum containing functional anti-Pseudomonas aeruginosa antibodies

Brief summary: 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: 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)

Primary outcomes:
measure: Isolation of recombinant human monoclonal antibodies against Pseudomonas aeruginosa
timeFrame: 1 day
Secondary outcomes:
measure: Isolation of functional antibodies against Pseudomonas aeruginosa
timeFrame: 1 day
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Chu Grenoble Alpes
Study officials:
affiliation: University Hospital, Grenoble
name: Yvan CASPAR, Dr
role: PRINCIPAL_INVESTIGATOR
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