Implementation of an Outpatient Parenteral Antimicrobial Therapy Program

Not Applicable

Recruiting

• Conditions: Outpatient
• Interventions: Other: Place of treatment

• Registration Number: NCT05707507
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-16
• Study First Submitted QC: 2023-01-28
• Last Update Submitted: 2023-01-28
• Study Start: 2023-02-01
• Study First Posted: 2023-02-01
• Last Update Posted: 2023-02-01
• Primary Completion: 2024-01-10
• Study Completion: 2024-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inpatient antimicrobial therapy	Place of treatment	Included patients will receive intrahospital antimicrobial therapy according to their infectious disease.
Outpatient antimicrobial therapy	Place of treatment	Included patients will receive outpatient antimicrobial therapy according to their infectious disease.

Primary Outcome Measures

Name	Time	Method
Cost changes with an Outpatient Parenteral Antimicrobial Therapy Program (OPAT) treatment compared to standard intrahospital therapy.	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Saved bed days	1 year	The bed days saved will be determined by calculating the number of days between the start and end of care at OPAT.

Trial Locations

Locations (1)

Hospital Universitario José E. Gonzalez; 🇲🇽 Monterrey, Nuevo Leon, Mexico