Status:
NOT_YET_RECRUITING
Antimicrobial Resistant Organism Decolonization After Microbiome Perturbation
Lead Sponsor:
University Health Network, Toronto
Conditions:
Gram-negative Bacteremia
Microbial Colonization
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
ARO-DECAMP is a multi-centre, placebo-controlled, pilot and feasibility randomized controlled trial for the microbial consortium Microbial Ecosystem Therapeutic-2. Non-intensive care unit patients ≥ 1...
Detailed Description
Reconstituting the perturbed microbiome is a novel therapeutic modality with the potential to decrease ARO colonization and infection and combat AMR without additional pressure for selection of furthe...
Eligibility Criteria
Inclusion
- Adult (≥18 years old) inpatient not admitted to the ICU or equivalent (step-up and step-down units are eligible)
- Positive blood culture with an ARO:
- AmpC beta-lactamase producing species: Enterobacter cloacae, Citrobacter spp., Klebsiella aerogenes, Serratia spp., Morganella morganii, Hafnia alvei OR
- ESBL-producing gram-negative bacilli
- Currently receiving treatment for the bloodstream infection
Exclusion
- Inability to swallow oral MET-2 or placebo capsule
- Recipient of small bowel transplant
- Inflammatory bowel disease, short bowel syndrome, diverting/non-diverting ileo/colostomy
- Use of \>3 days over-the-counter or prescription probiotics (not including food additives) within 10 days of enrolment
- Receipt of fecal microbiota transplant (FMT) within 3 months of enrolment
- Absolute neutrophil count \<0.5x109/L
- Death expected within 72 hours of enrolment
- Planned continuation of non-prophylaxis antimicrobial therapy active against the bloodstream isolate for \>42 days
- Known pregnancy, planning to become pregnant during the study period, or breastfeeding
- Any other reason in view of the site investigator or treating team
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06214403
Start Date
July 1 2025
End Date
July 1 2027
Last Update
December 4 2024
Active Locations (4)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
3
University Health Network
Toronto, Ontario, Canada, M5G 1L7
4
Sinai Health
Toronto, Ontario, Canada, M6G 1X5