Status:
COMPLETED
Monoclonal Antibodies in Clostridium Difficile Infection
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut Pasteur
Conditions:
Clostridium Infection
Eligibility:
All Genders
18+ years
Phase:
NA
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 f...
Detailed Description
Immunoglobulin A (IgA), the major mucosal antibody, plays a key role in maintaining the diversity of the intestinal microbiota and eliminating intestinal pathogens. They modulate microbiota compositio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04874623
Start Date
November 29 2021
End Date
September 28 2022
Last Update
October 4 2022
Active Locations (1)
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1
Maladies infectieuses et tropicales, Hôpital Pitié-Salpêtrière
Paris, France, 75013