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Outpatient Parenteral Antimicrobial Therapy (OPAT)

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ClinicalTrials.gov Identifier: NCT03221140
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Serge de Valliere, University of Lausanne Hospitals

Brief 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. 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.

Condition or disease Intervention/treatment
Infections Drug: Outpatient parenteral antimicrobial therapy

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.


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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study About the Feasibility, Safety and Efficacy of Outpatient Parenteral Antimicrobial Therapy (OPAT)
Actual Study Start Date : January 1, 2014
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics


Intervention Details:
  • Drug: Outpatient parenteral antimicrobial therapy
    Administration of intravenous antimicrobials on an outpatient basis
    Other Name: OPAT


Primary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients referred to the OPAT unit of Lausanne Unversity Hospital
Criteria

Inclusion Criteria:

  • Patients referred to the OPAT unit of Lausanne University Hospital

Exclusion Criteria:

  • Unable to give informed consent
  • Refusing participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221140


Contacts
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Contact: Serge de Valliere, MD, MSc +41 79 556 43 12 serge.de-valliere@hospvd.ch

Locations
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Switzerland
Department of Outpatient Care and Community Medicine, University Hospital of Lausanne Recruiting
Lausanne, Switzerland, 1011
Contact: Serge de Valliere, MD    +41 21 314 48 52    serge.de-valliere@hospvd.ch   
Principal Investigator: Serge de Valliere, MD         
Sponsors and Collaborators
University of Lausanne Hospitals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Serge de Valliere, MD,MSc, Principal Investigator, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT03221140     History of Changes
Other Study ID Numbers: 34/14
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anti-Infective Agents
Anti-Bacterial Agents