Implementation of an Outpatient Parenteral Antimicrobial Therapy Program

Hospital Universitario Dr. Jose E. Gonzalez

Status: Enrolling

Conditions: Outpatient

Treatments: Other: Place of treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05707507

IF22-00011

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Outpatient antimicrobial therapy

Active Comparator group

Description:

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

Treatment:

Other: Place of treatment

Inpatient antimicrobial therapy

Other group

Description:

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

Treatment:

Other: Place of treatment