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

Stem Cell Transplant Complications Clinical Trial

— VANCALLO  

Official title:

Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant: a Double-blind Placebo-controlled Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05256693
• Other study ID #: APHP210089
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 2022
• Est. completion date: July 2025

Study information

• Verified date: November 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Inès Boussen, MD
• Phone: +33 1 42 49 90 66
• Email: ines.boussen[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 336
• Est. completion date: July 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Clostridium Difficile Infections
• Clostridium Infections
• Communicable Diseases
• Infections
• Stem Cell Transplant Complications

Intervention

Drug:
• Vancomycin
Oral vancomycin (powder) 125mg twice a day
• Placebo
Vancomycine placebo (powder) twice a day

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	GIRCI Ile de France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	12 weeks
Secondary	Cumulative incidence of Clostridium difficile infection	Time between inclusion and Clostridium difficile infection, occurring before hospital discharge or the end of study treatment (that is 5 weeks from inclusion if the patient is still hospitalized), 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	Proportion of patients with Clostridium difficile infection by PCR testing	Clostridium difficile infection defined as a diarrhea (> 3 loose stools/day) with positive toxinogenic Clostridium difficile PCR (polymerase chain reaction) testing, without other obvious etiology for diarrhea nor pseudo-membraneous colitis (endoscopy, colectomy, autopsy).	5 weeks
Secondary	Factors associated with the proportion of patients with Clostridium difficile infection	Candidate factors associated with Clostridium difficile infection: antibiotics, toxinogenic strain at baseline, microbiota composition	5 weeks
Secondary	Proportion of patients with severe Clostridium difficile infection	Severe Clostridium difficile infection defined as at least one of the following: fulminans colitis, toxic megacolon, dehydration, neutrophils blood count>20000/mm3, general deterioration	5 weeks
Secondary	Proportion of patients with bacterial infection	Bacterial infection defined as occurrence of a bacterial infection (any site)	5 weeks
Secondary	Proportion of patients with vancomycin-resistant enterococcus carriage	Carriage defined as occurrence of vancomycin-resistant enterococcus carriage on rectal swab	5 weeks
Secondary	Gut microbiome profile	Evolution of gut microbiome profile during the study	12 weeks
Secondary	Nosocomial Clostridium difficile infection clusters	Defined as at least 2 cases of Clostridium difficile infection in the department within 12 weeks	12 weeks
Secondary	Proportion of patients with Graft-versus-Host disease	Graft-versus-Host disease, acute or chronic, grade 2 to 4	12 months
Secondary	Cumulative incidence of relapse	Time between inclusion and hemopathy relapse or last follow-up, up to a maximum of 12 months	12 months
Secondary	Treatment-related mortality	Proportion of death related to allogeneic stem cell transplant procedures	5 weeks
Secondary	Overall survival	Time between inclusion and death or last follow-up, up to a maximum of 12 months	12 months