Monoclonal Antibodies in Clostridium Difficile Infection

NCT04874623 | Completed

• 1 other identifier: APHP180354
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Immunoglobulin A (IgA), the major mucosal antibody, plays a key role in maintaining diversity of the intestinal microbiota and eliminating intestinal pathogens. Dysbiosis is an important risk factor for Clostridium difficile infection, which is the leading cause of nosocomial diarrhea in industrialized countries. This study aims to develop IgA monoclonal antibodies targeting C. difficile surface proteins.

Conditions

Clostridium Infection

Keywords

Clostridium difficile infection; Therapeutic monoclonal antibodies

Outcome Measures

Primary Outcomes (1)

• Generate C. difficile specific antibodies from circulating memory B lymphocytes of C. difficile patients.

  The presence of SlpA and Cwp84 specific memory B cells will be assessed from a single sample per patient. After separation of blood mononuclear cells, specific memory B cells will be selected using microfluidic drop technology. The variable VH and VL fragments of the immunoglobulins, which define the specificity of the antibodies, will be sequenced for each selected B cell. The corresponding antibodies will then be produced in a well-established cell line.

  From the blood samples taken between Day 1 and Day 7 after the diagnostic of CDI

Secondary Outcomes (2)

• Antibody affinity assessment

  From the blood samples taken between Day1 and Day7 after the diagnostic of CDI

• Neutralizing capacity evaluation affinity

  From the blood samples taken between Day1 and Day7 after the diagnostic of CDI

Study Arms (1)

CDI

EXPERIMENTAL

Other: Collection of peripheral blood mononuclear cells

Interventions

Collection of peripheral blood mononuclear cells OTHER

Analysis of specific memory B cells in CDI patients

CDI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patient, 18 years of age
• diarrhea and/or abdominal pain.
• Presence of C. difficile toxins in feces
• Patient having dated and signed informed consent.

You may not qualify if:

• pregnant or nursing women
• adult under guardianship
• Ileus
• Peritonitis
• Pseudomembranous colitis
• Hemodynamic instability
• Fever ≥ 38.5°C
• Shivers
• Respiratory failure
• Leukocytosis \> 15x109/L
• Serum creatinin \>50% reference values)
• Serum lactate \> 5mM
• Serum Albumine \< 30g/l
• Other diarrhea cause
• Humoral immunodeficiency

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut Pasteur: collaborator

Study Sites (1)

Maladies infectieuses et tropicales, Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Baptiste Hervier

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: May 6, 2021
• Study Start: November 29, 2021
• Primary Completion: November 29, 2021
• Study Completion: September 28, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)