Outpatient Parenteral Antimicrobial Therapy (OPAT)

NCT03221140 | Unknown

• 1 other identifier: 34/14
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections

Outcome Measures

Primary Outcomes (3)

• 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.

  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)

  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.

  2014-2020

Interventions

Outpatient parenteral antimicrobial therapy DRUG

Administration of intravenous antimicrobials on an outpatient basis

Also known as: OPAT

Eligibility Criteria

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

Study Population

All patients referred to the OPAT unit of Lausanne Unversity Hospital

You may qualify if:

• Patients referred to the OPAT unit of Lausanne University Hospital

You may not qualify if:

• Unable to give informed consent
• Refusing participation

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Department of Outpatient Care and Community Medicine, University Hospital of Lausanne

Lausanne, 1011, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 29982449 DERIVED

MeSH Terms

Conditions

Infections

Central Study Contacts

Serge de Valliere, MD, MSc

CONTACT

+41 79 556 43 12; serge.de-valliere@hospvd.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,MSc, Principal Investigator

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 18, 2017
• Study Start: January 1, 2014
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)