InfectionsNCT03221140
Outpatient Parenteral Antimicrobial Therapy (OPAT)
An observational study of Infections, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
Outpatient parenteral antimicrobial therapy (OPAT) has been recognised as a useful, cost-effective and safe alternative to inpatient treatment, but no formal OPAT unit existed in Switzerland until recently. In December 2013 an OPAT unit was established at Lausanne University Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections
- What is being tested?
- Outpatient parenteral antimicrobial therapy
- Type of treatment
- Injection or infusion
- How many people
- 2,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2014to 31 Dec 2025
- Phase
- Observational
- 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
Study population: All patients referred to the OPAT unit of Lausanne Unversity Hospital
Who may be able to join
- Patients referred to the OPAT unit of Lausanne University Hospital
Who cannot join
- Unable to give informed consent
- Refusing participation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Outpatient Care and Community Medicine, University Hospital of Lausanne
Lausanne, 1011
Serge de Valliere, MD, +41 21 314 48 52, serge.de-valliere@hospvd.ch
Serge de Valliere, MD
About this study
Official title: Observational Study About the Feasibility, Safety and Efficacy of Outpatient Parenteral Antimicrobial Therapy (OPAT)
Outpatient parenteral antimicrobial therapy (OPAT) has been recognised as a useful, cost-effective and safe alternative to inpatient treatment, but no formal OPAT unit existed in Switzerland until recently. In December 2013 an OPAT unit was established at Lausanne University Hospital. The investigators plan to investigate the efficacy, safety and economicity of outpatient parenteral antimicrobial therapy administered at the new OPAT unit of the Lausanne University Hospital starting in January 2014 until December 2020.
Read the detailed description
Some patients require parenteral antibiotic therapy, but are well enough to return home. Outpatient parenteral antimicrobial therapy (OPAT) was first developed in the USA in the 1970s for patients with cystic fibrosis, before being adopted by other countries. It has been recognised as a useful, cost-effective and safe alternative to inpatient treatment. It is now a standard care in several countries and different national guidelines have been established. There are various models of care for OPAT and most OPAT centres provide hospital-centred nursing programmes or services based on nurses visiting the patient's home. A few centres have also shown that self-administration of intravenous antibiotic therapy is an effective and safe option for selected patients. Furthermore, use of continuous infusion of antibiotics increases the number of feasible treatments. Continuous infusion by pumps of antibiotics with a time-dependent killing mechanism is a practical option which has been described. In Europe, even if many infectious disease specialists feel that OPAT is required, it is still underdeveloped because of lack of funding, lack of leadership and lack of coordination between hospitals and community care.
In the last decades, programs to enhance care delivery on an outpatient basis in order to contain health costs have been developed in Switzerland. However administration of outpatient intravenous antibiotic therapy for patients who require parenteral therapy, but are otherwise fit enough to go home, hasn't been used widely until recently. In December 2013, an outpatient parenteral antibiotic treatment (OPAT) unit was initiated at Lausanne University Hospital with the goal of offering an alternative treatment programme that is equally effective and as safe as inpatient treatment.
The purpose of this study will be to investigate the efficacy, safety and economicity of treatments administered at the new OPAT unit of the University Hospital of Lausanne in the context of the Swiss Health System.
- Conditions
- Infections
- Being tested
- Outpatient parenteral antimicrobial therapy
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient parenteral antimicrobial therapyDrug
Also called OPAT
Administration of intravenous antimicrobials on an outpatient basis
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of treatment outcomes
Efficacy of OPAT will be evaluated by recording the treatment outcome. Patients will be categorized 3 months after end of treatment as cured, as treatment failure or as a relapse according to the following definitions:
- cured: absence of fever and no clinical sign of the site of infection.
- treatment failure: patient readmitted to hospital because of infection related complications
- relapse: patients considered as cured at the end of OPAT, but who had again signs of infection at the same site within 3 months after end of OPAT.
Measured: 2014-2020
Evaluation of the incidence of adverse events
Evaluation of the safety of OPAT will be done by measuring the rate of adverse events and their severity during OPAT. All adverse events will be recorded and classified according to their severity according the grade classification (grade 1 to 5) as recommended by the Common Terminology Criteria for Adverse Events (CTCAE). (https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf)
Measured: 2014-2020
Economic evaluation
The cost of outpatient parenteral antimicrobial treatments will be estimated and compared to similar economic evaluations of other centres published in the literature.
Measured: 2014-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Jan 2014
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serge de Valliere, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221140
- Sponsor's protocol ID
- 34/14
- Status last verified
- Dec 2023
- First submitted
- 27 Jun 2017
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Voumard R, Gardiol C, Andre P, Arensdorff L, Cochet C, Boillat-Blanco N, Decosterd L, Buclin T, de Valliere S. Efficacy and safety of continuous infusions with elastomeric pumps for outpatient parenteral antimicrobial therapy (OPAT): an observational study. J Antimicrob Chemother. 2018 Sep 1;73(9):2540-2545. doi: 10.1093/jac/dky224.
PubMed 29982449
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study About the Feasibility, Safety and Efficacy of Outpatient Parenteral Antimicrobial Therapy (OPAT)
- ClinicalTrials.gov ID
- NCT03221140
- Acronym / sponsor ID
- 34/14
- Conditions
- Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Jul 2017 (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.
Outpatient parenteral antimicrobial therapy (OPAT) has been recognised as a useful, cost-effective and safe alternative to inpatient treatment, but no formal OPAT unit existed in Switzerland until recently. In December 2013 an OPAT unit was established at Lausanne University Hospital. The investigators plan to investigate the efficacy, safety and economicity of outpatient parenteral antimicrobial therapy administered at the new OPAT unit of the Lausanne University Hospital starting in January 2014 until December 2020.
Detailed description
Some patients require parenteral antibiotic therapy, but are well enough to return home. Outpatient parenteral antimicrobial therapy (OPAT) was first developed in the USA in the 1970s for patients with cystic fibrosis, before being adopted by other countries. It has been recognised as a useful, cost-effective and safe alternative to inpatient treatment. It is now a standard care in several countries and different national guidelines have been established. There are various models of care for OPAT and most OPAT centres provide hospital-centred nursing programmes or services based on nurses visiting the patient's home. A few centres have also shown that self-administration of intravenous antibiotic therapy is an effective and safe option for selected patients. Furthermore, use of continuous infusion of antibiotics increases the number of feasible treatments. Continuous infusion by pumps of antibiotics with a time-dependent killing mechanism is a practical option which has been described. In Europe, even if many infectious disease specialists feel that OPAT is required, it is still underdeveloped because of lack of funding, lack of leadership and lack of coordination between hospitals and community care.
In the last decades, programs to enhance care delivery on an outpatient basis in order to contain health costs have been developed in Switzerland. However administration of outpatient intravenous antibiotic therapy for patients who require parenteral therapy, but are otherwise fit enough to go home, hasn't been used widely until recently. In December 2013, an outpatient parenteral antibiotic treatment (OPAT) unit was initiated at Lausanne University Hospital with the goal of offering an alternative treatment programme that is equally effective and as safe as inpatient treatment.
The purpose of this study will be to investigate the efficacy, safety and economicity of treatments administered at the new OPAT unit of the University Hospital of Lausanne in the context of the Swiss Health System.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred to the OPAT unit of Lausanne Unversity Hospital
Key inclusion criteria (1 listed)
- Patients referred to the OPAT unit of Lausanne University Hospital
Key exclusion criteria (2 listed)
- Unable to give informed consent
- Refusing participation
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 |
|---|---|---|
| Outpatient parenteral antimicrobial therapyAlso: OPATAdministration of intravenous antimicrobials on an outpatient basis | Drug | – |
Primary outcome
Evaluation of treatment outcomes
Time frame: 2014-2020
Efficacy of OPAT will be evaluated by recording the treatment outcome. Patients will be categorized 3 months after end of treatment as cured, as treatment failure or as a relapse according to the following definitions: * cured: absence of fever and no clinical sign of the site of infection. * treatment failure: patient readmitted to hospital because of infection related complications * relapse: patients considered as cured at the end of OPAT, but who had again signs of infection at the same site within 3 months after end of OPAT.
Evaluation of the incidence of adverse events
Time frame: 2014-2020
Evaluation of the safety of OPAT will be done by measuring the rate of adverse events and their severity during OPAT. All adverse events will be recorded and classified according to their severity according the grade classification (grade 1 to 5) as recommended by the Common Terminology Criteria for Adverse Events (CTCAE). (https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf)
Economic evaluation
Time frame: 2014-2020
The cost of outpatient parenteral antimicrobial treatments will be estimated and compared to similar economic evaluations of other centres published in the literature.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Derived from this study: PubMed 29982449Voumard R, Gardiol C, Andre P, Arensdorff L, Cochet C, Boillat-Blanco N, Decosterd L, Buclin T, de Valliere S. Efficacy and safety of continuous infusions with elastomeric pumps for outpatient parenteral antimicrobial therapy (OPAT): an observational study. J Antimicrob Chemother. 2018 Sep 1;73(9):2540-2545. doi: 10.1093/jac/dky224.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Dec 2023. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serge de Valliere, MD, MSc (+41 79 556 43 12, serge.de-valliere@hospvd.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of treatment outcomes (time frame: 2014-2020). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03221140, which also lists 1 linked publication.
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 15 Dec 2023.