Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant

NCT05256693 | Unknown Phase 3 DMC

• 1 other identifier: APHP210089
• Study Type: interventional
• Target: 336
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clostridium difficile (CD) infection are an important cause of morbi-mortality in patients undergoing allogeneic hematopoietic stem cell transplant (HSCT). The VANCALLO trial aims at evaluating oral vancomycine reducing the risk of CD infection relying on a placebo controlled 1:1 randomized design, including one interim analysis.

Conditions

Clostridium Difficile Infections; Stem Cell Transplant Complications

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with Clostridium difficile infection

  Clostridium difficile infection defined as a diarrhea (\> 3 loose stools/day) with positive Clostridium difficile testing and free-toxin in stools by enzyme-linked immunosorbent assay (ELISA), without other obvious etiology for diarrhea nor pseudo-membraneous colitis (endoscopy, colectomy, autopsy).

  5 weeks

Secondary Outcomes (13)

• Proportion of patients with Clostridium difficile infection

  12 weeks

• Cumulative incidence of Clostridium difficile infection

  5 weeks

• Proportion of patients with Clostridium difficile infection by PCR testing

  5 weeks

• Factors associated with the proportion of patients with Clostridium difficile infection

  5 weeks

• Proportion of patients with severe Clostridium difficile infection

  5 weeks

Study Arms (2)

Vancomycine

EXPERIMENTAL

Oral vancomycine 125 mg twice a day, from inclusion (at the time of hospitalization for allogeneic stem cell transplant) until hospital discharge or 5 weeks in hospital at most.

Drug: Vancomycin

Placebo

PLACEBO COMPARATOR

Vancomycine placebo, twice a day, from inclusion (at the time of hospitalization for allogeneic stem cell transplant) until hospital discharge or 5 weeks in hospital at most.

Drug: Placebo

Interventions

Vancomycin DRUG

Oral vancomycin (powder) 125mg twice a day

Vancomycine

Placebo DRUG

Vancomycine placebo (powder) twice a day

Placebo

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥15 ans
• Hospitalization since less than 72 hours, for an allogeneic stem cell transplant, whichever the indication and conditioning
• For men and women of reproductive age: use of contraceptives
• Informed consent
• Healthcare insurance

You may not qualify if:

• Know allergy or history of adverse events with vancomycine
• Pregnancy
• History of total colectomy and/or inflammatory bowel disease
• Digestive decontamination protocol for the stem cell transplant procedure

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• GIRCI Ile de France: collaborator

MeSH Terms

Conditions

Clostridium Infections

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Inès Boussen, MD

CONTACT

+33 1 42 49 90 66; ines.boussen@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 25, 2022
• Study Start: March 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2025
• Last Updated: February 25, 2022

Record last verified: 2021-11