Trials Sponsors Conditions Drugs Pricing

Conditions

Clostridium Infection

Keywords

Clostridium difficile infectionTherapeutic 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 cellsOther

Analysis of specific memory B cells in CDI patients

CDI

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

adult patient, 18 years of age
diarrhea and/or abdominal pain.

Sponsors & Collaborators

Institut Pasteur
Industrycollaborator
Assistance Publique - Hôpitaux de Paris
Otherlead

Study Sites (1)

Maladies infectieuses et tropicales, Hôpital Pitié-Salpêtrière

Paris, 75013, France

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

Baptiste Hervier
Assistance Publique - Hôpitaux de Paris
PRINCIPAL INVESTIGATOR

Enrollment

15 participants (actual enrollment reported by the registry).

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

Actual (reported)

Monoclonal Antibodies in Clostridium Difficile Infection

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

CDI

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

CDI

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations