MET-2 for Bacterial Blood Infections

(ARO-DECAMP Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called MET-2, studied for its potential to combat antibiotic-resistant bacterial blood infections. The goal is to determine if MET-2 can effectively clear these infections and if it is practical for patient use. Participants will receive either MET-2 or a placebo for 10 days and will be monitored for 180 days to track progress. This trial may suit adults who are hospitalized, not in intensive care, and currently receiving treatment for a bacterial blood infection that responds poorly to standard antibiotics. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments like MET-2 are under study for their safety and effectiveness in treating bacterial blood infections. Although detailed safety information from earlier studies on MET-2 isn't provided here, its presence in a Phase 2 trial suggests some initial evidence of safety. This phase typically indicates that the treatment has been safe enough in earlier tests to involve more participants.

Phase 2 trials primarily aim to assess how well participants tolerate the treatment and to monitor for any side effects. At this stage, researchers generally believe the treatment is safe enough for further testing, but they still closely monitor participants. Trial participants receive careful monitoring to manage any side effects promptly.

Prospective participants should discuss any concerns with the trial team. The team can provide more detailed information specific to individual health and the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard antibiotics used to treat bacterial blood infections, MET-2 is a groundbreaking treatment that uses live bacteria to restore balance in the body's microbiome. Researchers are excited about MET-2 because it introduces a new mechanism of action by directly replenishing beneficial bacteria, potentially strengthening the body's natural defenses against infection. This approach is different from traditional antibiotics, which often kill both harmful and beneficial bacteria, sometimes leading to resistance issues. MET-2's potential to quickly bolster the microbiome makes it a promising candidate for more effective and faster relief from bacterial blood infections.

What evidence suggests that MET-2 might be an effective treatment for bacterial blood infections?

Research has shown that MET-2, a treatment using beneficial bacteria, might help treat bacterial blood infections, particularly those resistant to antibiotics. This trial will compare MET-2 with a placebo to evaluate its effectiveness. MET-2 restores balance in the body, potentially leading to better health. Although specific data on MET-2's effectiveness for blood infections is limited, similar treatments have improved gut and immune health in other cases. This suggests that MET-2 could be a useful option for treating bacterial blood infections. More research is needed to fully understand its benefits, but early results are promising. ^{6 7 8 9 10}

Who Is on the Research Team?

Bryan Coburn, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2249678/

Improving early management of bloodstream infection Strong evidence for giving antibiotics as quickly as possible in bloodstream infection comes from a large North American study of patients with septic shock in ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2831846

Seven vs Fourteen Days of Antibiotics for Gram-Negative ... These findings suggest that most Gram-negative bloodstream infections can be treated with 7 days of antibiotics unless there is a concern for inadequate source ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8172964/

Clinical Profile, Prognostic Factors, and Outcome Prediction in ... It is estimated that at least 23 per 100,000 people die each year shortly following an episode of BSI (2).

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2796617

Association of Follow-up Blood Cultures With Mortality in ... This study revealed that obtaining FUBCs was associated with decreased mortality, highlighted the challenges of using unadjusted mortality data ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0933365724002501

Advances in diagnosis and prognosis of bacteraemia, ... This manuscript offers a detailed survey of machine-learning techniques used for the diagnosis and prognosis of bacteraemia, bloodstream infections, and sepsis

6. withpower.com withpower.com/trial/phase-2-infections-1-2024-624aa

MET-2 for Bacterial Blood Infections (ARO-DECAMP Trial) However, it mentions that you cannot continue non-prophylaxis antimicrobial therapy for more than 42 days if it is active against the bloodstream infection.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10534394/

Bacteremia in Patients with Sepsis in the ICU - PubMed Central Bacteremia appears to be associated with higher mortality rates and length of ICU stay in comparison with nonbacteremic counterparts.

8. cdc.gov cdc.gov/healthcare-associated-infections/php/data/progress-report.html

Current HAI Progress Report Information about national and state-level HAI data from 2023, measured using the standardized infection ratio (SIR).

9. jem-journal.com jem-journal.com/article/S0736-4679(23)00594-2/fulltext

Evaluating Clinical Prediction Rules for Bacteremia ... Of the total blood cultures collected, 476 (12%) were positive for bacterial growth, of which 400 (10%) were true positives and 76 (2%) were ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6520165/

Transfusion-transmitted Infections reported to the National ... Of the 54/111 reported TTIs that met inclusion criteria, 37/54 (69%) were bacterial, 16/54 (30%) were parasitic, and 1/54 (2%) was viral. The most frequently ...