ABAC-IBS: Isolation of Human Recombinant Therapeutic Monoclonal Anti-Pseudomonas Antibodies

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Recruiting
CT.gov ID
NCT04335383
Collaborator
(none)
10
1
26.9
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Isolation of anti-Pseudomonas antibodies from type B lymphocytes

Study Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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
Actual Study Start Date :
Oct 5, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Grenoble Alpes Grenoble France 38043

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

  • Principal Investigator: Yvan CASPAR, Dr, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT04335383
Other Study ID Numbers:
  • 38RC20.048
  • 2020-A00311-38
First Posted:
Apr 6, 2020
Last Update Posted:
May 9, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Grenoble
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2022