MET-2 for Bacterial Blood Infections

(ARO-DECAMP Trial)

Recruiting at 3 trial locations

Overseen By Bryan Coburn, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University Health Network, Toronto

Must be taking: Antibiotics

Must not be taking: Probiotics

Disqualifiers: Inflammatory bowel disease, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you cannot continue non-prophylaxis antimicrobial therapy for more than 42 days if it is active against the bloodstream infection.

How is the drug MET-2 different from other treatments for bacterial blood infections?

The research provided does not contain specific information about MET-2, so it's unclear how it differs from other treatments for bacterial blood infections. ^{1 2 3 4 5}

What is the purpose of this 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.

Research Team

Bryan Coburn, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for adults over 18 who are not in intensive care but have a bloodstream infection with antibiotic-resistant bacteria. They must be currently receiving treatment for this infection to qualify.

Inclusion Criteria

I am currently being treated for a bloodstream infection.

I am 18 or older and hospitalized but not in intensive care.

My blood test shows an infection with specific bacteria resistant to some antibiotics.

Exclusion Criteria

I will continue taking antibiotics effective against my infection for more than 42 days.

I have received a small bowel transplant.

I have a condition affecting my intestines, such as IBD, short bowel, or I have an ileo/colostomy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either MET-2 or placebo for 10 days, with an initial loading dose followed by a maintenance dose

10 days

Daily administration

Follow-up

Participants are monitored for safety, effectiveness, and biomarker outcomes after treatment

180 days

Periodic sample collection

Treatment Details

Interventions

• MET-2
• Placebo

Trial Overview The study tests MET-2, a microbial consortium, against a placebo in patients with bacterial blood infections resistant to antibiotics. Participants will randomly receive either MET-2 or the placebo for 10 days and will be monitored for six months.

Participant Groups

Group I: MET-2 Experimental Treatment 1 Intervention

Participants randomized to the intervention will receive MET-2 daily for 10 days. MET-2 capsules are administered orally at 0.5 g per capsule, containing 3.1 x 10\^5-10\^11 colony forming units (CFU). An initial loading dose of 10 MET-2 capsules/day will be taken for 2 days (5 grams total). For the following 8 days, participants will take a maintenance dose of 3 MET-2 capsules/day (1.5 grams total).

Group II: Placebo Placebo Group 1 Intervention

Participants randomized to the placebo will receive microcrystalline cellulose in a capsule, identical in appearance to MET-2 but not containing live bacteria. Participants will take the placebo in the same dosing schedule as the MET-2 arm: 10 capsules daily for 2 days, followed by 3 capsules daily for 8 days.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

External Validity of a Randomized Controlled Trial on Duration of Antibiotics for the Treatment of Gram-Negative Bacteremia. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Recombinant methionyl human granulocyte colony-stimulating factor for the prevention and treatment of non-neutropenic infectious diseases. [2019]

3. Japan pubmed.ncbi.nlm.nih.gov

Utility of Blood Culture in Patients with Community-Acquired Pneumonia: A Propensity Score-Matched Analysis Based on a Japanese National Health Insurance Database. [2023]

4. Japan pubmed.ncbi.nlm.nih.gov

[Blood culture: gold standard for definitive diagnosis of bacterial and fungal infections--from the laboratory aspect]. [2011]

5. England pubmed.ncbi.nlm.nih.gov

How representative is a point-of-care randomized trial? Clinical outcomes of patients excluded from a point-of-care randomized controlled trial evaluating antibiotic duration for Gram-negative bacteraemia: a multicentre prospective observational cohort study. [2022]