Antimicrobial Resistant Organism Decolonization After Microbiome Perturbation

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Jan 9, 2024

Keywords

ClinConnect Summary

The ARO-DECAMP trial is a research study aimed at finding out how well a new treatment called Microbial Ecosystem Therapeutic-2 (MET-2) works for adults who have a bloodstream infection caused by antibiotic-resistant bacteria. This trial will include patients who are at least 18 years old and are currently being treated for these infections but are not in intensive care. Participants will be randomly assigned to receive either the MET-2 treatment or a placebo (a non-active treatment) for 10 days. The researchers want to see how many people join the study and stick with the treatment, and they will follow participants for up to 180 days to collect information on their health.

To be eligible for this study, participants must have a confirmed bloodstream infection caused by specific types of antibiotic-resistant bacteria. However, some individuals will not be able to join, such as those who have certain medical conditions affecting their digestive system or are about to start other long-term antibiotic treatments. Throughout the trial, participants can expect to have their health monitored closely and provide biological samples to help researchers understand the impact of the treatment. This study is important because it aims to help develop new ways to treat infections that are difficult to manage due to antibiotic resistance.

Gender

ALL

Eligibility criteria

• 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