Implementation of an Outpatient Parenteral Antimicrobial Therapy Program

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez (Other)
Overall Status
Recruiting
CT.gov ID
NCT05707507
Collaborator
(none)
40
1
2
11.3
3.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Place of treatment
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Implementation of an Outpatient Parenteral Antimicrobial Therapy Program
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jan 10, 2024
Anticipated Study Completion Date :
Jan 10, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Outpatient antimicrobial therapy

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

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.

Other: Inpatient antimicrobial therapy

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

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitario José E. Gonzalez Monterrey Nuevo Leon Mexico 64460

Sponsors and Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Adrian Camacho-Ortiz, Head of Infectious Diseases Department, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT05707507
Other Study ID Numbers:
  • IF22-00011
First Posted:
Feb 1, 2023
Last Update Posted:
Feb 1, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Adrian Camacho-Ortiz, Head of Infectious Diseases Department, Hospital Universitario Dr. Jose E. Gonzalez

Study Results

No Results Posted as of Feb 1, 2023