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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06214403
Other study ID # 23-5419
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date July 2024
Est. completion date July 2026

Study information

Verified date May 2024
Source University Health Network, Toronto
Contact Bryan Coburn, MD, PhD
Phone 416-634-7457
Email bryan.coburn@uhn.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 ≥ 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.


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 further antimicrobial resistance. No trial has yet assessed the potential of a therapeutic microbial consortium for ARO decolonization and infection prevention after antibiotic treatment. The investigational product, Microbial Ecosystem Therapeutic-2 (MET-2), is a defined microbial community derived from healthy donor stool. MET capsules are orally administered mixtures of bacterial strains cultured from the stool of a healthy donor. This study is designed to determine if a trial of administration of MET-2 after antibiotic treatment for bloodstream infections is feasible. Stool and plasma biomarkers to assess the effects of the intervention will also be evaluated.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
MET-2
Microbial Ecosystem Therapeutics (MET) is a defined microbial community derived from healthy donor stool. MET capsules are orally administered mixtures of pure cultures of human-derived bacterial strains.
Placebo
Microcrystalline Cellulose

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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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