Clostridium Difficile InfectionsPhase 3VANCALLONCT05256693
Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
A Phase 3 study testing Vancomycin in people with Clostridium Difficile Infections and Stem Cell Transplant Complications, run by Assistance Publique - Hôpitaux de Paris.
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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Clostridium Difficile Infections, Stem Cell Transplant Complications
- What is being tested?
- Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Being tested
- Vancomycin, Placebo
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Oral vancomycin (powder) 125mg twice a day
PlaceboDrug
Vancomycine placebo (powder) twice a day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 weeks
Secondary outcomes (13)
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).
Measured: 12 weeks
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).
Measured: 5 weeks
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).
Measured: 5 weeks
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
Measured: 5 weeks
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
Measured: 5 weeks
Proportion of patients with bacterial infection
Bacterial infection defined as occurrence of a bacterial infection (any site)
Measured: 5 weeks
Proportion of patients with vancomycin-resistant enterococcus carriage
Carriage defined as occurrence of vancomycin-resistant enterococcus carriage on rectal swab
Measured: 5 weeks
Gut microbiome profile
Evolution of gut microbiome profile during the study
Measured: 12 weeks
Nosocomial Clostridium difficile infection clusters
Defined as at least 2 cases of Clostridium difficile infection in the department within 12 weeks
Measured: 12 weeks
Proportion of patients with Graft-versus-Host disease
Graft-versus-Host disease, acute or chronic, grade 2 to 4
Measured: 12 months
Cumulative incidence of relapse
Time between inclusion and hemopathy relapse or last follow-up, up to a maximum of 12 months
Measured: 12 months
Treatment-related mortality
Proportion of death related to allogeneic stem cell transplant procedures
Measured: 5 weeks
Overall survival
Time between inclusion and death or last follow-up, up to a maximum of 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study startMar 2022 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- GIRCI Ile de France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256693
- Sponsor's protocol ID
- APHP210089
- Acronym
- VANCALLO
- Status last verified
- Nov 2021
- First submitted
- 28 Jan 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05256693
- Acronym / sponsor ID
- VANCALLO / APHP210089
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- GIRCI Ile de France
- Study start
- Mar 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycine | Experimental | Drug: VancomycinOral 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. |
| Placebo | Placebo comparator | Drug: PlaceboVancomycine 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VancomycinOral vancomycin (powder) 125mg twice a day | Drug | Vancomycine |
| PlaceboVancomycine placebo (powder) twice a day | Drug | Placebo |
Primary outcome
Proportion of patients with Clostridium difficile infection
Time frame: 5 weeks
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).
13 secondary outcomes
Proportion of patients with Clostridium difficile infection
Time frame: 12 weeks
Cumulative incidence of Clostridium difficile infection
Time frame: 5 weeks
Proportion of patients with Clostridium difficile infection by PCR testing
Time frame: 5 weeks
Factors associated with the proportion of patients with Clostridium difficile infection
Time frame: 5 weeks
Proportion of patients with severe Clostridium difficile infection
Time frame: 5 weeks
Proportion of patients with bacterial infection
Time frame: 5 weeks
Proportion of patients with vancomycin-resistant enterococcus carriage
Time frame: 5 weeks
Gut microbiome profile
Time frame: 12 weeks
Nosocomial Clostridium difficile infection clusters
Time frame: 12 weeks
Proportion of patients with Graft-versus-Host disease
Time frame: 12 months
Cumulative incidence of relapse
Time frame: 12 months
Treatment-related mortality
Time frame: 5 weeks
Overall survival
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vancomycin in people with Clostridium Difficile Infections and Stem Cell Transplant Complications, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inès Boussen, MD (+33 1 42 49 90 66, ines.boussen@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Clostridium difficile infection (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.