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NCT Number: NCT04335383

Isolation of Human Recombinant Therapeutic Monoclonal Anti-Pseudomonas Antibodies

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.

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Key information

Conditions

Pseudomonas Aeruginosa Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Multi-antibiotic Resistance Pseudomonas Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Isolation of anti-Pseudomonas antibodies from type B lymphocytes

Biological

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.

Primary outcomes

  1. Isolation of recombinant human monoclonal antibodies against Pseudomonas aeruginosa

    Time frame: 1 day

    Detection of binding of recombinant antibodies to Pseudomonas aeruginosa target proteins by ELISA assay.

Secondary outcomes

  1. Isolation of functional antibodies against Pseudomonas aeruginosa

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Yvan CASPAR, Dr

CONTACT

[email protected]

+33 4 76 76 54 79

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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

Acronym: ABAC-IBS

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2020
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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