Outpatient antibiotic therapy administered as a continuous infusion using a pump
| ISRCTN | ISRCTN13982454 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13982454 |
| Protocol serial number | ASN 2025-4706 |
| Sponsor | Karolinska Institutet |
| Funder | Stockholm Region Innovation Fund |
- Submission date
- 13/01/2026
- Registration date
- 26/01/2026
- Last edited
- 26/01/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
For severe infections, intravenous antibiotic treatment is often necessary, and this typically requires hospitalization. Hospital admissions for this reason are increasing, but home-based treatment through Outpatient Parenteral Antibiotic Therapy (OPAT) offers a potential alternative for selected patients. A major challenge is that intravenous antibiotics are usually administered three to four times daily, making home-based administration highly resource-intensive. A novel solution involves elastomeric pumps (EP), which are replaced once a day and allow continuous infusion (CI) of antibiotics over 24 hours with minimal healthcare support (OPAT/EP). This approach appears promising but requires thorough evaluation of its effectiveness, patient safety, and impact on healthcare resource utilization. Therefore, this study aims to evaluate the effect of OPAT/EP regarding clinical and pharmacological treatment outcomes, cost-effectiveness and patient and provider satisfaction.
Who can participate?
All adults treated with intravenous antibiotic therapy for an infection and who need prolonged intravenous treatment, but who do not otherwise need inpatient hospital care are eligible for inclusion.
What does the study involve?
Eligible, consenting inpatients will transition to antibiotic treatment using CI with EP during hospitalization and then complete their treatment at home under OPAT/EP. Plasma antibiotic levels will be monitored to ensure dosing targets are achieved. Side effects, hospital-acquired infections, and other complications will be followed alongside treatment outcomes. Patients’ and healthcare professionals’ experiences will be assessed through questionnaires and focus group discussions. Additionally, a health economic analysis will compare the costs of OPAT/EP with conventional inpatient care and OPAT using intermittent administration.
What are the possible benefits and risks of participating?
The hypothesis is that OPAT/EP is a favourable treatment option, reducing hospital stays and overall care costs while improving convenience for both patients and healthcare providers. The main benefit to the individual patient is the ability to be freer in their everyday life with OPAT/EP compared to conventional intermittent treatment, as the EP is changed once a day instead of 3-4 times daily.
Potential risks: OPAT/EP is a safe form of administration that has been used in other medical fields (e.g. oncology) and in other countries in the past. We do not expect worse outcomes for the patients who receive this treatment compared to patients who are given the current standard. However, to ensure that care is not inferior to OPAT/EP, outcomes and any adverse events will be closely monitored. Venous blood samples will be collected from patients. Venous blood sampling is done by puncture through the skin into a blood vessel in the arm. This can cause slight discomfort to the patient and also has a very small risk of infection. Information will also be collected from patients' medical records, and the risk of data being disclosed must always be considered. Other ethical issues that are considered are related to privacy in focus groups, where participants discuss perceptions of OPAT/EP and when responding to patient surveys. However, the questions that will be used are considered sensitive, and similar questions have been used in other studies when patients have been asked to give feedback on their experiences of the care received.
Where is the study run from?
Stockholm South General Hospital (Södersjukhuset), Sweden.
When is the study starting and for how long is it expected to run?
June 2025 to December 2027.
Who is funding the study?
Stockholm Region’s Innovation Fund, Sweden.
Who is the main contact:
Jaran Eriksen, specialist physician and Associate Professor, Karolinska Institutet and Stockholm South General Hospital, jaran.eriksen@ki.se
Contact information
Public, Scientific, Principal investigator
Infektion/Venhälsan
Södersjukhuset
Sjukhusbacken 10
Stockholm
11883
Sweden
 ORCID ID |
0000-0003-1146-5615 |
|---|---|
| Phone | +46812361759 |
| jaran.eriksen@ki.se |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational study of outcomes, pharmacokinetics, patients and staff experiences and health economy of outpatient parenteral antibiotic treatment administered through elastomeric pumps. |
| Secondary study design | Case-control study |
| Scientific title | Outpatient Parenteral Antibiotic Therapy (OPAT) administered as continuous infusion by elastomeric pumps: Outcomes, pharmacokinetics, patient and staff experiences, and cost |
| Study acronym | OPAT/EP |
| Study objectives | To evaluate the pharmacokinetics, treatment outcomes, adverse effects, economic aspects, as well as patient and staff perceptions of outpatient parenteral antibiotic treatment (OPAT) administered as continuous infusion using elastomeric pumps (OPAT/EP). Specific Objectives: 1. To assess whether OPAT/EP achieves the same outcomes as intravenous intermittent antibiotic treatment in hospital. 2. To assess whether OPAT/EP achieves antibiotic plasma concentrations above MIC (minimum inhibitory concentration) for the bacteria being treated, throughout the whole treatment interval. 3. To measure stability of the antibiotic in the elastomeric pump throughout the dosing interval. 4. To assess the cost of using OPAT/EP in comparison to other care options. 5. To explore patients’, patient relatives’ and health care providers’ perceptions of OPAT/EP. |
| Ethics approval(s) |
Approved 04/11/2024, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, Uppsala, 750 02, Sweden; +46-10-475 08 00; registrator@etikprovning.se), ref: Dnr 2024-06603-01 |
| Health condition(s) or problem(s) studied | Antibiotic treatment of infectious diseases, e.g. endocarditis, orthopaedic infections |
| Intervention | Patients will be included in the studies while they are still inpatients receiving antibiotic treatment with standard intermittent dosing. Patients will be recruited from the ID wards or our partner wards where ID consultants give daily recommendations for treatments, e.g. orthopaedics, surgery and internal medicine. Before being discharged to home care, three blood samples for measuring plasma antibiotic concentrations will be taken (peak concentration, trough concentration and mid-dosing interval concentration). All patients are then discharged to home care using outpatient parenteral antibiotic therapy using elastomeric pumps (OPAT/EP) that provide 24-hour continuous infusion of antibiotics. On day three with OPAT/EP, two blood samples for antibiotic plasma concentration measurement will be taken (through and mid-interval concentrations). Length of antibiotic therapy varies from days to weeks and patients will be followed until 30 days after ending antibiotic treatment. |
| Intervention type | Drug/Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Antibiotic, elastomeric pump |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 110 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Patients aged 18 years or older 2. Treated with intravenous antibiotic therapy for an infection and who need prolonged intravenous treatment, but who do not otherwise need inpatient hospital care 3. All bacterial infections falling in this category 4. Treatments using cloxacillin, piperacillin/tazobactam, vancomycin and benzylpenicillin 5. Patients who consent to participate |
| Key exclusion criteria | 1. Inability to consent to participation for cognitive reasons, such as dementia 2. Insufficient knowledge of Swedish or English in combination with the absence of an authorized interpreter 3. Patients prescribed treatment other than those stated above (as stability for these antibiotics is poor and therefore cannot be given in the 24-hour continuous infusion pumps) |
| Date of first enrolment | 01/06/2025 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Stockholm
11883
Sweden
Stockholm
17164
Sweden
Enskededalen
12131
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and analysed during the current study will be made available upon request from Jaran Eriksen, jaran.eriksen@ki.se |
Editorial Notes
14/01/2026: Study’s existence confirmed by the Swedish Ethical Review Authority, Sweden.
