Study of antimicrobial resistance in patients receiving outpatient parenteral antimicrobial therapy
| ISRCTN | ISRCTN15309500 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15309500 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 273856 |
| Protocol serial number | A095421, IRAS 273856 |
| Sponsors | Cambridge University Hospitals NHS Foundation Trust, University of Cambridge |
| Funders | Academy of Medical Sciences and the Health Foundation, National Institute for Health Research |
- Submission date
- 18/02/2020
- Registration date
- 20/02/2020
- Last edited
- 20/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Bacteria that are resistant to antibiotics are becoming an important problem in hospitals and much research has been carried out to try to reduce the rates. Unwell patients in hospital who have received long antibiotic courses have a high risk of developing infections with antibiotic-resistant bacteria. Patients who are in the community and have received long courses of antibiotics may be at risk but few studies have been done to explore this. Therefore, this study will help clinicians understand how gut bacteria changes, and may become more resistant, after a long course of antibiotics, in a community-based population. In the future this could help clinicians choose better antibiotics for each individual patient. It could help stop the spread of antibiotic-resistant bacteria in hospital by showing when clinicians need to use special infection control measures such as the use of gloves, aprons or gowns, or ensuring certain patients have their own toilet or room.
Who can participate?
Patients aged 18 or older who are expected to receive 2 or more weeks of IV antibiotics, and Infectious Diseases ward or clinic patients who have received no antimicrobial therapy within the last 3 months
What does the study involve?
This study explores how gut bacteria change and develop resistance in patients who have received long courses of intravenous antibiotics in the community. It compares bacteria in stool from participants who have received different intravenous antimicrobials (Outpatient Parenteral Antimicrobial Therapy (OPAT) patients) to participants who have not (a control group). Stool samples will be examined at enrolment, weekly during antimicrobial therapy, at 3 and 6 months. The OPAT group will provide a minimum of 4 stool samples and the control group will provide 3 stool samples. The OPAT group will provide more stool samples than the control group as they will have additional weekly stool samples collected at the time of their routine OPAT clinic visits. All stool samples will be self-collected by the participant and then handed to the study team. At the start of the study, the study team will collect the participant's clinical information from the medical records. This will include the following information: NHS number, date of birth, gender, ethnicity, weight, smoking status, alcohol intake, dietary requirements, probiotic or prebiotic use, travel abroad, contact with hospital in the last year, medical/surgical history, antibiotic use, medication history and any relevant symptoms they may have (such as diarrhoea or vomiting.) The weekly face-to-face return visits to OPAT clinic are part of the usual care if the participant is receiving therapy. At return visits the participant will be asked about any relevant symptoms they may have (such as diarrhoea or vomiting,) any new hospital contact, infections or recent antibiotics they may have received since their last visit. The 3 and 6 month follow up visits may be completed face-to-face or remotely, via telephone consultation, with the study team member. At 3 and 6 month return visits the participant will be asked about any relevant symptoms they may have (such as diarrhoea or vomiting), any new hospital contact, infections or recent antibiotics they may have received since their last visit. The 6-month visit marks the end of the study period for each participant.
What are the possible benefits and risks of participating?
There are no direct benefits to participants for taking part in the study. However, the information that the study team obtain from the study may help future patients and enable doctors to reduce the spread of antibiotic-resistant gut bacteria. There are no direct risks to participants if they take part in this study. There may be some inconvenience associated with the donation of stool samples during the study, as they need to be dropped off at the clinic, at the 3 and 6 month follow up period, by the participant, friend or family member. If the participant is found to have antibiotic-resistant gut bacteria they will be informed and should not be concerned. This information will be recorded in their medical electronic records so that it can be used in the future to ensure they receive the right antibiotics and, if necessary, access to a private room.
Where is the study run from?
Addenbrooke’s Hospital, CUH NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
September 2019 to August 2021
Who is funding the study?
1. Academy of Medical Sciences and the Health Foundation (UK)
2. National Institute for Health Research (UK)
Who is the main contact?
1. Dr Estee Torok
et317@cam.ac.uk
2. Dr Rachel Bousfield
rachel.bousfield@nhs.net
Contact information
Scientific
Principal Investigator
Department of Medicine, Box 157
Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223 336845 |
|---|---|
| et317@cam.ac.uk |
Public
Department of Medicine, Box 157
Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223 336845 |
|---|---|
| rachel.bousfield@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Evolution of antimicrobial resistance in patients receiving outpatient parenteral antimicrobial therapy |
| Study acronym | Study of AMR in OPAT patients |
| Study objectives | 1. How does the gut bacteria change, and does it become more resistant, after a long course of antibiotics in a community-based group of patients compared to those that have not received any antibiotics? 2. Specifically, are there differences that can be detected by testing for gut bacteria's antibiotic-resistance genes and does this difference affect the patient's health by increasing the chance of difficult-to-treat infections? 3. Also, are there differences we can detect by looking for the presence of resistant bacteria including multi-drug resistant organisms (MDRO) and does this difference affect the patient's health by increasing the chance of difficult to treat infections? |
| Ethics approval(s) | Approved 23/01/2020, East Midlands - Derby Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; Tel: +44 (0)2071048285; Email: NRESCommittee.EastMidlands-Derby@nhs.net), REC ref: 20/EM/0009 |
| Health condition(s) or problem(s) studied | Antimicrobial resistance (AMR) |
| Intervention | 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 received the intravenous antimicrobial ertapenem Group 4: have received the intravenous antimicrobial daptomycin Eligible participants will have been approached by a study team member during routine clinical care, will have discussed the study, and been provided with written information: the Participant Information leaflet. Participants who decide to take part in the study will sign a Consent form at enrolment. The study team will collect stool samples from participants at the start of the study and later at approximately 3 and 6 months. The Outpatient Parenteral Antimicrobial Therapy (OPAT) group will provide a minimum of 4 stool samples and the "control" group will provide 3 stool samples. The OPAT group will provide more stool samples than the control group as they will have additional weekly stool samples collected at the time of their routine OPAT clinic visits. All stool samples will be self-collected by the participant and then handed to the study team. At the start of the study, the study team will collect the participant's clinical information from the medical records. This will include the following information: NHS number, date of birth, gender, ethnicity, weight, smoking status, alcohol intake, dietary requirements, probiotic or prebiotic use, travel abroad, contact with hospital in the last year, medical/surgical history, antibiotic use, medication history and any relevant symptoms they may have (such as diarrhoea or vomiting). The weekly face-to-face return visits to OPAT clinic are part of the usual care if the participant is receiving therapy. At return visits the participant will be asked about any relevant symptoms they may have (such as diarrhoea or vomiting), any new hospital contact, infections or recent antibiotics they may have received since their last visit. The 3 and 6 month follow up visits may be completed face-to-face or remotely, via telephone consultation, with the study team member. At 3 and 6 month return visits the participant will be asked about any relevant symptoms they may have (such as diarrhoea or vomiting,) any new hospital contact, infections or recent antibiotics they may have received since their last visit. The 6-month visit marks the end of the study period for each participant. |
| Intervention type | Other |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
1. Risk factors for carriage of ARGs, measured using correlation between the presence of ARGs and the presence of certain clinical characteristics at baseline |
| Completion date | 18/08/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 19/02/2020 |
| Date of final enrolment | 21/04/2021 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Cambridge
CB2 0QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The dataset will be held at Addenbrooke’s Hospital, CUH NHS Foundation Trust, UK. It will not be made fully available as the dataset will contain patient identifiable information and clinical details regarding medical conditions and treatment outcomes. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Other unpublished results | 20/06/2024 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 2.0 | 23/01/2020 | 16/09/2022 | No | No |
Additional files
- ISRCTN15309500_Protocol _v2.0_23Jan2020.pdf
- Protocol file
- ISRCTN15309500_Results_2023.pdf
- Other unpublished results
Editorial Notes
20/06/2024: The following changes were made:
1. A study contact was updated.
2. Results were uploaded.
16/09/2022: Protocol file uploaded.
19/04/2021: The total final enrolment was added.
16/10/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 21/10/2020 to 21/04/2021.
2. The overall trial end date was changed from 18/02/2021 to 18/08/2021.
3. The intention to publish date was changed from 01/01/2023 to 01/07/2023.
4. Recruitment to this study is no longer paused.
09/04/2020: Due to current public health guidance, recruitment for this study has been paused.
19/02/2020: Trial's existence confirmed by East Midlands - Derby Research Ethics Committee.
