Outpatient Parenteral Antimicrobial Therapy (OPAT)

Infections Clinical Trial

Official title:

Observational Study About the Feasibility, Safety and Efficacy of Outpatient Parenteral Antimicrobial Therapy (OPAT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03221140
• Other study ID #: 34/14
• Status: Recruiting
• Start date: January 1, 2014
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: University of Lausanne Hospitals
• Contact: Serge de Valliere, MD, MSc
• Phone: +41 79 556 43 12
• Email: serge.de-valliere[@]hospvd.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients referred to the OPAT unit of Lausanne University Hospital

Exclusion Criteria:

• Unable to give informed consent

• Refusing participation

Related Conditions & MeSH terms

• Infections

Intervention

Drug:
• Outpatient parenteral antimicrobial therapy
Administration of intravenous antimicrobials on an outpatient basis

Locations

Country	Name	City	State
Switzerland	Department of Outpatient Care and Community Medicine, University Hospital of Lausanne	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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