NCT05707507

Brief Summary

To determine cost changes with an Outpatient Parenteral Antimicrobial Therapy Program (OPAT) treatment compared to standard therapy while maintaining safety and efficacy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

January 16, 2023

Last Update Submit

January 28, 2023

Conditions

Outpatient

Keywords

OPATOutpatientMexico

Outcome Measures

Primary Outcomes (1)

  • Cost changes with an Outpatient Parenteral Antimicrobial Therapy Program (OPAT) treatment compared to standard intrahospital therapy.

    Total OPAT costs will be estimated from actual costs and readmissions costs after adverse events that would not have occurred if patients had been treated as inpatients. Actual costs will be obtained from the annual financial records of the service during the study period. These will include staff salaries, medications, equipment, and other costs. To estimate the costs of conventional care that would have been incurred if patients were treated as inpatients, it will be assumed that intrahospital stay would be equal to the OPAT care with the same diagnosis.

    1 year

Secondary Outcomes (1)

  • Saved bed days

    1 year

Study Arms (2)

Outpatient antimicrobial therapy

ACTIVE COMPARATOR

Included patients will receive outpatient antimicrobial therapy according to their infectious disease.

Other: Place of treatment

Inpatient antimicrobial therapy

OTHER

Included patients will receive intrahospital antimicrobial therapy according to their infectious disease.

Other: Place of treatment

Interventions

Place of treatmentOTHER

Patients with an infectious diseases have to be treated with a specify antimicrobial therapy. The differences between the arms is about the possibility to continue with the treatment in or out of the hospital.

Inpatient antimicrobial therapyOutpatient antimicrobial therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Infectious disease confirmed
  • Need to be treated for 3 or more days
  • Suitable catheter/venous access

You may not qualify if:

  • Patients who have to be hospitalized for other cause
  • Age \< 18 years
  • Pregnancy
  • Not appropriate catheter/venous access
  • Patients who changed of hospital
  • Patients who got any other medical insurance
  • Patients absent for treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario José E. Gonzalez

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Related Publications (5)

  • Psaltikidis EM, Silva END, Moretti ML, Trabasso P, Stucchi RSB, Aoki FH, Cardoso LGO, Hofling CC, Bachur LF, Ponchet DDF, Colombrini MRC, Tozzi CS, Ramos RF, Costa SMQ, Resende MR. Cost-utility analysis of outpatient parenteral antimicrobial therapy (OPAT) in the Brazilian national health system. Expert Rev Pharmacoecon Outcomes Res. 2019 Jun;19(3):341-352. doi: 10.1080/14737167.2019.1541404. Epub 2018 Nov 5.

    PMID: 30362845RESULT

  • Seaton RA, Barr DA. Outpatient parenteral antibiotic therapy: principles and practice. Eur J Intern Med. 2013 Oct;24(7):617-23. doi: 10.1016/j.ejim.2013.03.014. Epub 2013 Apr 18.

    PMID: 23602223RESULT

  • Bernard L, El-Hajj, Pron B, Lotthe A, Gleizes V, Signoret F, Denormandie P, Gaillard JL, Perronne C. Outpatient parenteral antimicrobial therapy (OPAT) for the treatment of osteomyelitis: evaluation of efficacy, tolerance and cost. J Clin Pharm Ther. 2001 Dec;26(6):445-51. doi: 10.1046/j.1365-2710.2001.00380.x.

    PMID: 11722682RESULT

  • Amodeo MR, Clulow T, Lainchbury J, Murdoch DR, Gallagher K, Dyer A, Metcalf SL, Pithie AD, Chambers ST. Outpatient intravenous treatment for infective endocarditis: safety, effectiveness and one-year outcomes. J Infect. 2009 Dec;59(6):387-93. doi: 10.1016/j.jinf.2009.09.009. Epub 2009 Sep 17.

    PMID: 19766136RESULT

  • Durojaiye OC, Bell H, Andrews D, Ntziora F, Cartwright K. Clinical efficacy, cost analysis and patient acceptability of outpatient parenteral antibiotic therapy (OPAT): a decade of Sheffield (UK) OPAT service. Int J Antimicrob Agents. 2018 Jan;51(1):26-32. doi: 10.1016/j.ijantimicag.2017.03.016. Epub 2017 Jun 30.

    PMID: 28673610RESULT

Central Study Contacts

Adrian Camacho Ortiz, PhD

CONTACT

81230812acamacho_md@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Infectious Diseases Department

Study Record Dates

First Submitted

January 16, 2023

First Posted

February 1, 2023

Study Start

February 1, 2023

Primary Completion

January 10, 2024

Study Completion

January 10, 2024

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)