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Study of antimicrobial resistance in patients receiving outpatient parenteral antimicrobial therapy

Evolution of antimicrobial resistance in patients receiving outpatient parenteral antimicrobial therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN15309500
Enrollment
40
Registered
2020-02-20
Start date
2020-02-19
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antimicrobial resistance (AMR) Infections and Infestations

Interventions

This study involves 4 groups. Each group contains 10 patients: Group 1: have not received intravenous antimicrobials Group 2: have received the intravenous antimicrobial ceftriaxone Group 3: have rece

Sponsors

Cambridge University Hospitals NHS Foundation Trust
Lead Sponsor
University of Cambridge
Collaborator

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Contacts

Public ContactRachel Bousfield
rachel.bousfield@nhs.net+44 (0)1223 336845

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026