ElastoMeric Infusion Pumps for Hospital AntibioTICs

NCT05150015 | Completed DMC

• 1 other identifier: 21/1358
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infection, Bacterial

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (15)

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

  6 months

• Number (%) of screened patients consented (recruitment)

  6 months

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

  6 months

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

  6 months

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

  6 months

Study Arms (1)

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

EXPERIMENTAL

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

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

Single arm study

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stuart Bond: lead

Study Sites (1)

Mid Yorkshire Hospitals NHS Trust

Wakefield, West Yorkshire, WF14DG, United Kingdom

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-chief investigator

Model Details: Pilot feasability study

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 8, 2021
• Study Start: May 7, 2022
• Primary Completion: December 1, 2022
• Study Completion: September 1, 2024
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)