Implementation of an Outpatient Parenteral Antimicrobial Therapy Program

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

Detailed Description
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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.

Official Title
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Implementation of an Outpatient Parenteral Antimicrobial Therapy Program

Conditions
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Outpatient

Intervention / Treatment
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* Other: Place of treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Outpatient antimicrobial therapy<br>Included patients will receive outpatient antimicrobial therapy according to their infectious disease. | Other: Place of treatment<br>* 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.<br>|
| Other: Inpatient antimicrobial therapy<br>Included patients will receive intrahospital antimicrobial therapy according to their infectious disease. | Other: Place of treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OPAT, Outpatient, Mexico