Infection, BacterialEMPHATICNCT05150015
ElastoMeric Infusion Pumps for Hospital AntibioTICs
A study testing To assess the feasibility of giving intravenous antibiotics to adult inpatients using elastomeric infusion pumps (EMPs) in people with Infection, Bacterial, run by Stuart Bond at 1 site in United Kingdom.
Trial summary
Special pumps called self-deflating Elastomeric Pumps (EMPs) will be tested for giving antibiotics via a drip to hospital patients. EMPs are filled with antibiotics, attached to a "drip" (usually in the arm) and worn on the body, slowly giving antibiotics through the day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Bacterial
- What is being tested?
- To assess the feasibility of giving intravenous antibiotics to adult inpatients using elastomeric infusion pumps (EMPs)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 May 2022to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 18 years and over admitted to hospital with an infection requiring treatment for 7 days or more with intravenous flucloxacillin, piperacillin/tazobactam or benzylpenicillin Clinically stable and improving as assessed by the hospital medical consultant and likely to be well enough for discharge in the next two weeks.
- Able to provide written consent or witnessed consent
Who cannot join
- Unable to receive an appropriate vascular access device, such as a peripherally inserted central catheter (PICC) Penicillin allergy and unsuitable to receive penicillin challenge or desensitisation.
- Requires a combination of intravenous antibiotics, any of which needs to be given more often than once daily.
- Requires transfer to another hospital Unsuitable for outpatient parenteral antibiotic treatment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Mid Yorkshire Hospitals NHS Trust
Wakefield, West Yorkshire, WF14DG
About this study
Special pumps called self-deflating Elastomeric Pumps (EMPs) will be tested for giving antibiotics via a drip to hospital patients. EMPs are filled with antibiotics, attached to a "drip" (usually in the arm) and worn on the body, slowly giving antibiotics through the day. EMPs are often used to give antibiotics to patients in their own home but they have not been used to treat patients in hospital before, so a small study of 10 patients will be conducted to see if a full scale clinical trial is worthwhile. EMPs will be tested for ease of use and safety in hospital, and to find out what staff and patients think about them. The pilot will be done to see if a clinical trial would be good value for money by comparing time spent in hospital, nursing time and overall cost to the NHS of the two ways of giving antibiotics to patients.
Read the detailed description
4 Background 4.1 Antibiotic resistance Antibiotic resistance (AMR) is when bacteria have changed (mutated) so they can survive the effects of antibiotics, meaning antibiotics are less effective. AMR is a major threat to health worldwide. In UK hospitals, at least a third of patients are on antibiotics at any given time. Hospital patients with serious infections are often given intravenous antibiotics (through a "drip" into a vein). Cutting down unnecessary antibiotic prescribing is key to reducing resistance.
4.2 Problems giving intravenous antibiotics Giving intravenous antibiotics takes a lot of nursing time. This is made worse if antibiotics are needed more than once a day. Nurses are the only staff who give intravenous antibiotics in hospitals, and there is a shortage of 40,000 nurses in the NHS. Because of this, it is common for doses to be missed. The COVID-19 pandemic has increased the pressure on nurses' time. It is not always practical to give antibiotics 4 or 6 times a day so less effective antibiotics may be used instead.
4.3 What can be done to help? Some antibiotics work better when given slowly into a vein all the time. EMPs are self-powered devices that deliver antibiotics in this way.
EMPs:
- are currently used to give antibiotics to patients in their own homes
- are not used to give antibiotics to patients in hospitals because the safety, benefits and value for money have not been confirmed
- could allow more nurse time for patient care by reducing the time to set up antibiotic drips.
- could make things better for patients by allowing them to move more, sleep better, recover faster and spend less time in hospital
4.4 Designs and methods used Patients who could have antibiotics through EMPs will be identified from clinical ward rounds. EMPs will be tested for safety in hospital patients, as well as value for money in the NHS by collecting information about costs, nursing time and length of hospital stay. Surveys of patients and nursing staff will be conducted to explore how EMPs could be best used in hospital.
4.5 Patient and public involvement (PPI) This research has been driven by patients who know how difficult it is to keep mobile when attached to drip stands; how disturbed sleep from drips being set up in the night affects their wellbeing; and, how they are concerned about missed doses of antibiotics. The project has been designed with input from a PPI representative (Co-investigator Thompson) who has reviewed all project plans and materials.
4.6 Dissemination Findings will be published in medical journals and presented at conferences/NHS patient events. Social media will be used to let people know what is found and infographics will be developed to help communicate findings using social media. If appropriate, funding will be sought for a full trial.
- Conditions
- Infection, Bacterial
- Being tested
- To assess the feasibility of giving intravenous antibiotics to adult inpatients using elastomeric infusion pumps (EMPs)
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To assess the feasibility of giving intravenous antibiotics to adult inpatients using elastomeric infusion pumps (EMPs)Device
Single arm study
| Study group | Role | What they receive |
|---|---|---|
| Number of consented patients who complete the antibiotics through an elastomeric pump | Experimental | Flucloxacillin, piperacillin/taozbactam and benzylpenicillin will be use Receives: Device: To assess the feasibility of giving intravenous antibiotics to adult inpatients using elastomeric infusion pumps (EMPs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (%) of consented inpatients who complete the planned course of intravenous antibiotics through an EMP
Measured: 6 months
Secondary outcomes (15)
Number (%) of screened patients as identified by a microbiologist, antimicrobial pharmacist or the patient's clinical team
Measured: 6 months
Number (%) of screened patients consented (recruitment)
Measured: 6 months
Number (%) of consented patients who receive ≥1 dose of EMP
Measured: 6 months
Time (hrs) from electronic prescribing (with planned start date) of initial intravenous antibiotic to administration of first dose through EMP
Measured: 6 months
Time (hrs) from identification of medically fit for discharge to actual discharge
Measured: 6 months
Duration of hospital inpatient stay (days)
Measured: 6 months
Time (minutes) to order, procure, deliver and administer EMPs
Measured: 6 months
Clinical cure (resolution of symptoms) assessed by hospital medical consultant
Measured: 6 months
30-day mortality
Measured: 6 months
High residual volume in EMP (greater than 15% of 240mL = 36mL)
Measured: 6 months
Duration of total antibiotic course (days), including any early termination of planned treatment course and reason
Measured: 6 months
Description of antibiotic treatment pathway: intermittent, EMP, outpatient parenteral antibiotic therapy (OPAT), oral, cease
Measured: 6 months
Number of intravascular access devices required, including intermittent infusion period and EMP period
Measured: 6 months
Number (%) of missed and delayed doses from beginning of antibiotic course, either with intermittent infusion or EMP
Measured: 6 months
Time taken (hrs) to order, procure, deliver and administer antibiotics through EMPs
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start7 May 2022
- Primary completion1 Dec 2022
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot feasability study
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stuart Bond
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stuart Bond, Mid Yorkshire Teaching NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150015
- Sponsor's protocol ID
- 21/1358
- Acronym
- EMPHATIC
- Status last verified
- Sep 2025
- First submitted
- 22 Nov 2021
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ElastoMeric Infusion Pumps for Hospital AntibioTICs
- ClinicalTrials.gov ID
- NCT05150015
- Acronym / sponsor ID
- EMPHATIC / 21/1358
- Conditions
- Infection, Bacterial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Stuart BondUniversity, hospital or other
- Study start
- 7 May 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Special pumps called self-deflating Elastomeric Pumps (EMPs) will be tested for giving antibiotics via a drip to hospital patients. EMPs are filled with antibiotics, attached to a "drip" (usually in the arm) and worn on the body, slowly giving antibiotics through the day. EMPs are often used to give antibiotics to patients in their own home but they have not been used to treat patients in hospital before, so a small study of 10 patients will be conducted to see if a full scale clinical trial is worthwhile. EMPs will be tested for ease of use and safety in hospital, and to find out what staff and patients think about them. The pilot will be done to see if a clinical trial would be good value for money by comparing time spent in hospital, nursing time and overall cost to the NHS of the two ways of giving antibiotics to patients.
Detailed description
4 Background 4.1 Antibiotic resistance Antibiotic resistance (AMR) is when bacteria have changed (mutated) so they can survive the effects of antibiotics, meaning antibiotics are less effective. AMR is a major threat to health worldwide. In UK hospitals, at least a third of patients are on antibiotics at any given time. Hospital patients with serious infections are often given intravenous antibiotics (through a "drip" into a vein). Cutting down unnecessary antibiotic prescribing is key to reducing resistance.
4.2 Problems giving intravenous antibiotics Giving intravenous antibiotics takes a lot of nursing time. This is made worse if antibiotics are needed more than once a day. Nurses are the only staff who give intravenous antibiotics in hospitals, and there is a shortage of 40,000 nurses in the NHS. Because of this, it is common for doses to be missed. The COVID-19 pandemic has increased the pressure on nurses' time. It is not always practical to give antibiotics 4 or 6 times a day so less effective antibiotics may be used instead.
4.3 What can be done to help? Some antibiotics work better when given slowly into a vein all the time. EMPs are self-powered devices that deliver antibiotics in this way.
EMPs:
- are currently used to give antibiotics to patients in their own homes
- are not used to give antibiotics to patients in hospitals because the safety, benefits and value for money have not been confirmed
- could allow more nurse time for patient care by reducing the time to set up antibiotic drips.
- could make things better for patients by allowing them to move more, sleep better, recover faster and spend less time in hospital
4.4 Designs and methods used Patients who could have antibiotics through EMPs will be identified from clinical ward rounds. EMPs will be tested for safety in hospital patients, as well as value for money in the NHS by collecting information about costs, nursing time and length of hospital stay. Surveys of patients and nursing staff will be conducted to explore how EMPs could be best used in hospital.
4.5 Patient and public involvement (PPI) This research has been driven by patients who know how difficult it is to keep mobile when attached to drip stands; how disturbed sleep from drips being set up in the night affects their wellbeing; and, how they are concerned about missed doses of antibiotics. The project has been designed with input from a PPI representative (Co-investigator Thompson) who has reviewed all project plans and materials.
4.6 Dissemination Findings will be published in medical journals and presented at conferences/NHS patient events. Social media will be used to let people know what is found and infographics will be developed to help communicate findings using social media. If appropriate, funding will be sought for a full trial.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot feasability study
| Arm | Type | Receives |
|---|---|---|
| Number of consented patients who complete the antibiotics through an elastomeric pump | Experimental | Device: To assess the feasibility of giving intravenous antibiotics to adult inpatients using elastomeric infusion pumps (EMPs)Flucloxacillin, piperacillin/taozbactam and benzylpenicillin will be use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients 18 years and over admitted to hospital with an infection requiring treatment for 7 days or more with intravenous flucloxacillin, piperacillin/tazobactam or benzylpenicillin Clinically stable and improving as assessed by the hospital medical consultant and likely to be well enough for discharge in the next two weeks.
- Able to provide written consent or witnessed consent
Key exclusion criteria (3 listed)
- Unable to receive an appropriate vascular access device, such as a peripherally inserted central catheter (PICC) Penicillin allergy and unsuitable to receive penicillin challenge or desensitisation.
- Requires a combination of intravenous antibiotics, any of which needs to be given more often than once daily.
- Requires transfer to another hospital Unsuitable for outpatient parenteral antibiotic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| To assess the feasibility of giving intravenous antibiotics to adult inpatients using elastomeric infusion pumps (EMPs)Single arm study | Device | Number of consented patients who complete the antibiotics through an elastomeric pump |
Primary outcome
Number (%) of consented inpatients who complete the planned course of intravenous antibiotics through an EMP
Time frame: 6 months
15 secondary outcomes
Number (%) of screened patients as identified by a microbiologist, antimicrobial pharmacist or the patient's clinical team
Time frame: 6 months
Number (%) of screened patients consented (recruitment)
Time frame: 6 months
Number (%) of consented patients who receive ≥1 dose of EMP
Time frame: 6 months
Time (hrs) from electronic prescribing (with planned start date) of initial intravenous antibiotic to administration of first dose through EMP
Time frame: 6 months
Time (hrs) from identification of medically fit for discharge to actual discharge
Time frame: 6 months
Duration of hospital inpatient stay (days)
Time frame: 6 months
Time (minutes) to order, procure, deliver and administer EMPs
Time frame: 6 months
Clinical cure (resolution of symptoms) assessed by hospital medical consultant
Time frame: 6 months
30-day mortality
Time frame: 6 months
High residual volume in EMP (greater than 15% of 240mL = 36mL)
Time frame: 6 months
Duration of total antibiotic course (days), including any early termination of planned treatment course and reason
Time frame: 6 months
Description of antibiotic treatment pathway: intermittent, EMP, outpatient parenteral antibiotic therapy (OPAT), oral, cease
Time frame: 6 months
Number of intravascular access devices required, including intermittent infusion period and EMP period
Time frame: 6 months
Number (%) of missed and delayed doses from beginning of antibiotic course, either with intermittent infusion or EMP
Time frame: 6 months
Time taken (hrs) to order, procure, deliver and administer antibiotics through EMPs
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Infection, Bacterial
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing To assess the feasibility of giving intravenous antibiotics to adult inpatients using elastomeric infusion pumps (EMPs) in people with Infection, Bacterial, run by Stuart Bond at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number (%) of consented inpatients who complete the planned course of intravenous antibiotics through an EMP (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.