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Implementation of an Outpatient Parenteral Antimicrobial Therapy Program

Implementation of an Outpatient Parenteral Antimicrobial Therapy Program

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05707507
Enrollment
40
Registered
2023-02-01
Start date
2023-02-01
Completion date
2024-01-10
Last updated
2023-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Outpatient

Keywords

OPAT, Outpatient, Mexico

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.

Interventions

OTHERPlace 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.

Sponsors

Hospital Universitario Dr. Jose E. Gonzalez
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cost changes with an Outpatient Parenteral Antimicrobial Therapy Program (OPAT) treatment compared to standard intrahospital therapy.1 yearTotal 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

MeasureTime frameDescription
Saved bed days1 yearThe bed days saved will be determined by calculating the number of days between the start and end of care at OPAT.

Countries

Mexico

Contacts

Primary ContactAdrian Camacho Ortiz, PhD
acamacho_md@yahoo.com81230812

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026