Isolation of Human Recombinant Therapeutic Monoclonal Anti-Pseudomonas Antibodies

NCT ID: NCT04335383

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-05

Study Completion Date

2026-10-31

Brief Summary

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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

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Conditions

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Pseudomonas Aeruginosa Multi-antibiotic Resistance

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Isolation of anti-Pseudomonas antibodies from type B lymphocytes

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yvan CASPAR, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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Chu Grenoble Alpes

Grenoble, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Yvan CASPAR, Dr

Role: CONTACT

+33 4 76 76 54 79

Facility Contacts

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Yvan CASPAR, Dr

Role: primary

+33 (0)4 76 76 63 12

References

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DiGiandomenico A, Sellman BR. Antibacterial monoclonal antibodies: the next generation? Curr Opin Microbiol. 2015 Oct;27:78-85. doi: 10.1016/j.mib.2015.07.014. Epub 2015 Aug 25.

Reference Type BACKGROUND
PMID: 26302478 (View on PubMed)

Czaplewski L, Bax R, Clokie M, Dawson M, Fairhead H, Fischetti VA, Foster S, Gilmore BF, Hancock RE, Harper D, Henderson IR, Hilpert K, Jones BV, Kadioglu A, Knowles D, Olafsdottir S, Payne D, Projan S, Shaunak S, Silverman J, Thomas CM, Trust TJ, Warn P, Rex JH. Alternatives to antibiotics-a pipeline portfolio review. Lancet Infect Dis. 2016 Feb;16(2):239-51. doi: 10.1016/S1473-3099(15)00466-1. Epub 2016 Jan 13.

Reference Type BACKGROUND
PMID: 26795692 (View on PubMed)

Rappuoli R, Bottomley MJ, D'Oro U, Finco O, De Gregorio E. Reverse vaccinology 2.0: Human immunology instructs vaccine antigen design. J Exp Med. 2016 Apr 4;213(4):469-81. doi: 10.1084/jem.20151960. Epub 2016 Mar 28.

Reference Type BACKGROUND
PMID: 27022144 (View on PubMed)

Walker LM, Huber M, Doores KJ, Falkowska E, Pejchal R, Julien JP, Wang SK, Ramos A, Chan-Hui PY, Moyle M, Mitcham JL, Hammond PW, Olsen OA, Phung P, Fling S, Wong CH, Phogat S, Wrin T, Simek MD; Protocol G Principal Investigators; Koff WC, Wilson IA, Burton DR, Poignard P. Broad neutralization coverage of HIV by multiple highly potent antibodies. Nature. 2011 Sep 22;477(7365):466-70. doi: 10.1038/nature10373.

Reference Type BACKGROUND
PMID: 21849977 (View on PubMed)

Holzlohner P, Hanack K. Generation of Murine Monoclonal Antibodies by Hybridoma Technology. J Vis Exp. 2017 Jan 2;(119):54832. doi: 10.3791/54832.

Reference Type BACKGROUND
PMID: 28117810 (View on PubMed)

Other Identifiers

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2020-A00311-38

Identifier Type: OTHER

Identifier Source: secondary_id

38RC20.048

Identifier Type: -

Identifier Source: org_study_id

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