Status:

UNKNOWN

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

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Collaborating Sponsors:

GIRCI Ile de France

Conditions:

Clostridium Difficile Infections

Stem Cell Transplant Complications

Eligibility:

All Genders

15+ years

Phase:

PHASE3

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 v...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • Know allergy or history of adverse events with vancomycine
  • Pregnancy
  • Clostridium difficile infection within 30 days prior to inclusion or at inclusion
  • History of total colectomy and/or inflammatory bowel disease
  • Progressive diarrhea at inclusion, whichever the etiology
  • Digestive decontamination protocol for the stem cell transplant procedure
  • Participation to another drug clinical trial or being in the exclusion period from a prior clinical trial participation

Key Trial Info

Start Date :

March 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2025

Estimated Enrollment :

336 Patients enrolled

Trial Details

Trial ID

NCT05256693

Start Date

March 1 2022

End Date

July 1 2025

Last Update

February 25 2022

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