treatment of First Clostridium difficile infection episodes with bacteriotherapy

Phase 1

• Conditions: Clostridium difficile infection; MedDRA version: 20.0Level: LLTClassification code 10012748Term: Diarrhoea, Clostridium difficileSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2017-003147-38-ES
• Lead Sponsor: Emilio Bouza Santiago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-20
• Last Update Posted: 5 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Men and women
• Age> 18 years
• That they agree and are able to give their informed consent (patient or legal representative).
• Microbiological Diagnosis of toxigenic Clostridium difficile (ICD) infection with direct positive toxin test and diarrhea (> 3 bowel movements / 24 hours) or colonoscopic or histopathological findings that demonstrate pseudomembranous colitis within the first 72 hours before receiving the first dose of treatment.
• Patients who are in a first episode of ICD that meet criteria of risk of poor outcome.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

• Intensive care unit admission
• Pregnant or breatsfeeding patients at the signing of consent.
• Patients with neutropenia (with a total neutrophil count <0.5 x 109 / L)
• Enteritis by Salmonella, Shigella, E. coli 0157H7, Yersinia or Campylobacter.
• Severe baseline disease whose expected survival is less than three months.
• Patients with Child C cirrhosis
• Patients with current or recent (<3 months) treatment with antineoplastic agents or immunosuppressive medication (including but not limited to monoclonal antibodies to B and T cells, anti-TNF agents, antimetabolites (azathioprine, 6-mercaptopurine), inhibitors of calcineurin (tacrolimus, cyclosporine) mycophenolate mofetil.
• Patients with a history of severe allergy (anaphylactic) to food.
• Patients with known allergy or hypersensitivity to vancomycin or fidaxomicin.
• Patients with fever on the day planned for bacteriotherapy
• Gastroparesis
• known Chronic aspiration
• Dysfunction when swallowing or not oral-motor coordination
• Patients with any condition, which in the opinion of their physician, bacteriotherapy may endanger the health of the patient.
• Administration of any investigational antibiotic drug during the 30 days prior to inclusion in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified