Isolation of Human Recombinant Therapeutic Monoclonal Anti-Pseudomonas Antibodies

Recruiting

• Conditions: Pseudomonas Aeruginosa; Multi-antibiotic Resistance

• Registration Number: NCT04335383
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-06
• Study Start: 2020-10-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Isolation of recombinant human monoclonal antibodies against Pseudomonas aeruginosa	1 day	Detection of binding of recombinant antibodies to Pseudomonas aeruginosa target proteins by ELISA assay.

Secondary Outcome Measures

Name	Time	Method
Isolation of functional antibodies against Pseudomonas aeruginosa	1 day	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

Trial Locations

Locations (1)

Chu Grenoble Alpes; 🇫🇷 Grenoble, France