CClinicalTrials.gg
CompletedNCT05150015EMPHATICUpdated Sep 29, 2025

ElastoMeric Infusion Pumps for Hospital AntibioTICs

An interventional study of To assess the feasibility of giving intravenous antibiotics to adult inpatients using elastomeric infusion pumps (EMPs) in Infection, Bacterial, sponsored by Stuart Bond. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-29.

Sponsored by Stuart Bond · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Infection, Bacterial

Browse trials for

03

In context

Bacterial Infections

658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.

This study's enrollment of 9 is below the median of 84 across 405 interventional studies indexed under Bacterial Infections.

Browse Bacterial Infections studies →

Lead sponsor

This is the only study on the registry with Stuart Bond as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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

05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Number of consented patients who complete the antibiotics through an elastomeric pump

    Flucloxacillin, piperacillin/taozbactam and benzylpenicillin will be use

    Device: To assess the feasibility of giving intravenous antibiotics to adult inpatients using elastomeric infusion pumps (EMPs)

Interventions

  • DeviceTo assess the feasibility of giving intravenous antibiotics to adult inpatients using elastomeric infusion pumps (EMPs)

    Single arm study

06

What researchers measure

Primary outcomes

  1. Number (%) of consented inpatients who complete the planned course of intravenous antibiotics through an EMP

    Time frame: 6 months

Secondary outcomes

  1. Number (%) of screened patients as identified by a microbiologist, antimicrobial pharmacist or the patient's clinical team

    Time frame: 6 months

  2. Number (%) of screened patients consented (recruitment)

    Time frame: 6 months

  3. Number (%) of consented patients who receive ≥1 dose of EMP

    Time frame: 6 months

  4. Time (hrs) from electronic prescribing (with planned start date) of initial intravenous antibiotic to administration of first dose through EMP

    Time frame: 6 months

  5. Time (hrs) from identification of medically fit for discharge to actual discharge

    Time frame: 6 months

  6. Duration of hospital inpatient stay (days)

    Time frame: 6 months

  7. Time (minutes) to order, procure, deliver and administer EMPs

    Time frame: 6 months

  8. Clinical cure (resolution of symptoms) assessed by hospital medical consultant

    Time frame: 6 months

  9. 30-day mortality

    Time frame: 6 months

  10. High residual volume in EMP (greater than 15% of 240mL = 36mL)

    Time frame: 6 months

  11. Duration of total antibiotic course (days), including any early termination of planned treatment course and reason

    Time frame: 6 months

  12. Description of antibiotic treatment pathway: intermittent, EMP, outpatient parenteral antibiotic therapy (OPAT), oral, cease

    Time frame: 6 months

  13. Number of intravascular access devices required, including intermittent infusion period and EMP period

    Time frame: 6 months

  14. Number (%) of missed and delayed doses from beginning of antibiotic course, either with intermittent infusion or EMP

    Time frame: 6 months

  15. Time taken (hrs) to order, procure, deliver and administer antibiotics through EMPs

    Time frame: 6 months

07

Study locations

1 site
  • Mid Yorkshire Hospitals NHS Trust
    Wakefield, West Yorkshire WF14DG, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05150015
Lead sponsor
Stuart Bond
Responsible party
Stuart Bond (Co-chief investigator, Mid Yorkshire Teaching NHS Trust) — Sponsor-investigator
First posted
Dec 8, 2021
Start date
May 7, 2022
Primary completion
Dec 1, 2022
Completion
Sep 1, 2024
Last update
Sep 29, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion