Implementation of an Outpatient Parenteral Antimicrobial Therapy Program

Outpatient Clinical Trial

Official title:

Implementation of an Outpatient Parenteral Antimicrobial Therapy Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05707507
• Other study ID #: IF22-00011
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: January 10, 2024

Study information

• Verified date: January 2023
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: Adrian Camacho Ortiz, PhD
• Phone: 81230812
• Email: acamacho_md[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Patients will be evaluated during the period January 2023 to January 2024. Patients over 18 years admitted to the University Hospital Dr. José Eleuterio González with microbiological diagnosis of an infection that needs an intravenous antimicrobial treatment for more than three days, without other criteria to remain hospitalized. Informed consent will be provided to the patient, which is a requirement to enter the study, on it we will explain in detail the processes and follow-ups that you will have during participation in the study, as well as the confidentiality of personal data and results. After signing informed consent, patients will be randomized 1:1 to enter the OPAT group or the inpatient antimicrobial therapy group. Subjects will be stratified according to the diagnosed infection and will be followed within the protocol up to 30 after the end of the antimicrobial treatment established by the physician.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 10, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Outpatient

Intervention

Other:
• Place of treatment
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.

Locations

Country	Name	City	State
Mexico	Hospital Universitario José E. Gonzalez	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

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 — View Citation

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 — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Saved bed days	The bed days saved will be determined by calculating the number of days between the start and end of care at OPAT.	1 year