Pseudomonas AeruginosaABAC-IBSNCT04335383
Isolation of Human Recombinant Therapeutic Monoclonal Anti-Pseudomonas Antibodies
An observational study of Pseudomonas Aeruginosa and Multi-antibiotic Resistance, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudomonas Aeruginosa, Multi-antibiotic Resistance
- What is being tested?
- Isolation of anti-Pseudomonas antibodies from type B lymphocytes
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2020to Oct 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient previously infected or colonized by Pseudomonas aeruginosa with serum containing functional anti-Pseudomonas aeruginosa antibodies
Who may be able to join
- 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
Who cannot join
- Legally protected patient (minor, pregnant or nursing woman, ward or ward curated, hospitalized under duress or deprived of liberty)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Grenoble Alpes
Grenoble, 38043
Yvan CASPAR, Dr, +33 (0)4 76 76 63 12, YCaspar@chu-grenoble.fr
About this study
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
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.
- Being tested
- Isolation of anti-Pseudomonas antibodies from type B lymphocytes
- Keywords
- Pseudomonas aeruginosa, monoclonal antibody
- Medical subject headings
- Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolation of anti-Pseudomonas antibodies from type B lymphocytesBiological
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Isolation of recombinant human monoclonal antibodies against Pseudomonas aeruginosa
Detection of binding of recombinant antibodies to Pseudomonas aeruginosa target proteins by ELISA assay.
Measured: 1 day
Secondary outcomes (1)
Isolation of functional antibodies against Pseudomonas aeruginosa
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start5 Oct 2020
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pseudomonas AeruginosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yvan CASPAR, Dr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335383
- Sponsor's protocol ID
- 38RC20.048
- Other IDs
- 2020-A00311-38
- Acronym
- ABAC-IBS
- Status last verified
- Nov 2025
- First submitted
- 2 Apr 2020
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26302478Czaplewski 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.
PubMed 26795692Rappuoli 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.
PubMed 27022144Walker 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.
PubMed 21849977Holzlohner P, Hanack K. Generation of Murine Monoclonal Antibodies by Hybridoma Technology. J Vis Exp. 2017 Jan 2;(119):54832. doi: 10.3791/54832.
PubMed 28117810