Microbial Colonization Clinical Trial
— ARO-DECAMPOfficial title:
Antimicrobial Resistant Organism Decolonization After Microbiome Perturbation (ARO-DECAMP): a Multi-centre, Randomized, Placebo-controlled Feasibility Pilot Trial
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 ≥ 18 years old diagnosed with a bloodstream infection and receiving treatment for an antibiotic resistant organism will be included. Participants will be randomized to receive either MET-2 or placebo for 10 days. Recruitment rate and study intervention adherence will be evaluated for feasibility. Participants will be followed for 180 days, and biological samples will be collected periodically for clinical, ecological, and biomarker outcomes.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | July 2026 |
Est. primary completion date | January 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adult (=18 years old) inpatient not admitted to the ICU or equivalent (step-up and step-down units are eligible) 2. 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 3. Currently receiving treatment for the bloodstream infection Exclusion Criteria: 1. Inability to swallow oral MET-2 or placebo capsule 2. Recipient of small bowel transplant 3. Inflammatory bowel disease, short bowel syndrome, diverting/non-diverting ileo/colostomy 4. Use of >3 days over-the-counter or prescription probiotics (not including food additives) within 10 days of enrolment 5. Receipt of fecal microbiota transplant (FMT) within 3 months of enrolment 6. Absolute neutrophil count <0.5x109/L 7. Death expected within 72 hours of enrolment 8. Planned continuation of non-prophylaxis antimicrobial therapy active against the bloodstream isolate for >42 days 9. Known pregnancy, planning to become pregnant during the study period, or breastfeeding 10. Any other reason in view of the site investigator or treating team |
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital | Ottawa | Ontario |
Canada | Sinai Health | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse events | Frequency and grade | 180 days | |
Other | 90- and 180-day infection rate | Infection will be defined as either isolation of a pathogenic species from any sterile site OR the initiation of a therapeutic course of antimicrobials with or without isolation of a pathogenic species from a sterile or non-sterile site | 180 days | |
Other | ARO colonization by culture at 30 and 90 days post-intervention | Defined as any positive result for ARO from any site | 90 days | |
Other | Determine 90- and 180-day recurrence/re-infection rates (with the same organism) in each treatment arm | 180 days | ||
Other | AMR gene complement by sequencing at 30 and 90 days post-intervention | 90 days | ||
Other | 90- and 180-day all-cause mortality | 180 days | ||
Other | ICU and hospital lengths of stay | 180 days | ||
Other | C. difficile carriage at days 30 and 90 | 90 days | ||
Primary | Recruitment rate overall and by study site | Defined by the numbers of eligible, consented, and randomized patients | 1.5 years | |
Primary | Adherence to MET-2/placebo for the treatment duration | Defined as >80% of loading dose (16/20 pills) + >75% of daily doses (18/24 pills) for the maintenance period, as determined by returned unused capsules | 30 days | |
Secondary | Change in microbiome composition after intervention | Assessment of gut microbiome composition in pre- and post-randomization stool samples using bacterial culture and culture-independent (sequencing) assays. | 180 days | |
Secondary | Number of biomarker samples collected, by sample type and timepoint | Successful adherence to biomarker sample collection is defined as >80% of participants having samples suitable for analysis at 30 days post-intervention | 30 days | |
Secondary | Concentration of potential biomarkers in pre- and post-randomization blood and urine samples | Microbial-derived metabolites (short chain fatty acids and bile acids in blood, and 3-indoxyl sulfate in urine), markers of intestinal permeability (soluble CD14, LPS, LPS-binding protein, ZO-1, intestinal fatty acid protein), immune cell profiles (CD8 T lymphocytes, CD4 T lymphocytes, T regulatory cells, B lymphocytes, Th17 cells, Th1 cells). | 180 days |
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