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Microbial Ecosystem Therapeutic

MET-2 for Antibiotic Resistance (ARO-DECAMP Trial)

Phase 2

Waitlist Available

Led By Bryan Coburn, MD, PhD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently receiving treatment for the bloodstream infection

Adult (≥18 years old) inpatient not admitted to the ICU or equivalent (step-up and step-down units are eligible)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 years

Awards & highlights

ARO-DECAMP Trial Summary

This trial, called ARO-DECAMP, is testing a treatment called Microbial Ecosystem Therapeutic-2 (MET-2) for patients with antibiotic resistant bloodstream infections. The trial will include

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since specific side effects aren't listed, they may include typical reactions to new microbial treatments such as gastrointestinal discomfort, allergic responses, or temporary changes in bowel habits.

ARO-DECAMP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently being treated for a bloodstream infection.

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

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

ARO-DECAMP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to MET-2/placebo for the treatment duration

Recruitment rate overall and by study site

Secondary outcome measures

Change in microbiome composition after intervention

Concentration of potential biomarkers in pre- and post-randomization blood and urine samples

Number of biomarker samples collected, by sample type and timepoint

Other outcome measures

90- and 180-day all-cause mortality

90- and 180-day infection rate

AMR gene complement by sequencing at 30 and 90 days post-intervention

+5 more

ARO-DECAMP Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MET-2Experimental Treatment1 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: PlaceboPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MET-2

2017

Completed Phase 1

~70

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,080 Total Patients Enrolled

Bryan Coburn, MD, PhDPrincipal InvestigatorUniversity Health Network, Toronto

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for patients to participate in this study?

"According to the data presented on clinicaltrials.gov, this study is not currently seeking participants. It was initially posted on February 1st, 2024 and was last updated on January 9th, 2024. However, it's worth noting that there are presently 767 other ongoing clinical trials actively recruiting participants."

Answered by AI

Has MET-2 received the official endorsement of the FDA?

"Based on our assessment at Power, the safety rating for MET-2 is 2 out of 3. This score reflects that while there is some existing data supporting its safety, no evidence has been found yet to support its efficacy as this trial falls under Phase 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Antimicrobial Resistant Organism Decolonization After Microbiome Perturbation

2024. "Antimicrobial Resistant Organism Decolonization After Microbiome Perturbation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06214403.