Antimicrobial resistance (AMR) Infections and Infestations
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult (age 18 years older) 2. Male or female 3. Cases: patients expected to receive 2 or more weeks of IV antibiotics 4. Controls: an Infectious Diseases ward or clinic patient who has received no antimicrobial therapy within the last 3 months
Exclusion criteria
Exclusion criteria: 1. Patients with known previous MDRO colonisation (e.g. ESBL, CPE, VRE) 2. Those known to be pregnant 3. Does not fulfil study inclusion criteria 4. Declines or are unable to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of participants with stool carriage of specific Antimicrobial Resistance Genes (ARGs), measured using DNA/RNA extraction and testing using multiplex PCR for selected targets, at baseline, during antimicrobial therapy, and at 3 and 6 months 2. Number of participants with phenotypic evidence of Antimicrobial Resistance (AMR) organisms, measured using chromogenic agar for CPE, ESBL and VRE with resistant organisms undergoing identification using MALDI TOF MS (Bruker) and antimicrobial susceptibility testing using the Vitek-2 system (BioMerieux), at baseline, during antimicrobial therapy, and at 3 and 6 months 3. Number of participants with significant changes in the faecal microbiome diversity, measured using DNA library preparation and high-throughput microbial whole-genome sequencing, at selected timepoints including, for example, at baseline and 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Risk factors for carriage of ARGs, measured using correlation between the presence of ARGs and the presence of certain clinical characteristics at baseline 2. Clinical outcomes of patients with AMR organisms (e.g. clinical deterioration or death), measured using correlation between the presence of AMR organisms and the presence of certain clinical characteristics, within the 6-month follow-up period | — |
Countries
England, United Kingdom