Clinical trial NCT05707507: Implementation of an Outpatient Parenteral Antimicrobial Therapy Program
Official title: Implementation of an Outpatient Parenteral Antimicrobial Therapy Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Outpatient
Keywords: OPAT
Outpatient
Mexico
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cost changes with an Outpatient Parenteral Antimicrobial Therapy Program (OPAT) treatment compared to standard intrahospital therapy.
timeFrame: 1 year
Secondary outcomes:
measure: Saved bed days
timeFrame: 1 year
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario José E. Gonzalez
state: Nuevo Leon
Study officials:
References:
citation: Psaltikidis EM, Silva END, Moretti ML, Trabasso P, Stucchi RSB, Aoki FH, Cardoso LGO, Hofling CC, Bachur LF, Ponchet DDF, Colombrini MRC, Tozzi CS, Ramos RF, Costa SMQ, Resende MR. Cost-utility analysis of outpatient parenteral antimicrobial therapy (OPAT) in the Brazilian national health system. Expert Rev Pharmacoecon Outcomes Res. 2019 Jun;19(3):341-352. doi: 10.1080/14737167.2019.1541404. Epub 2018 Nov 5.
citation: Seaton RA, Barr DA. Outpatient parenteral antibiotic therapy: principles and practice. Eur J Intern Med. 2013 Oct;24(7):617-23. doi: 10.1016/j.ejim.2013.03.014. Epub 2013 Apr 18.
citation: Bernard L, El-Hajj, Pron B, Lotthe A, Gleizes V, Signoret F, Denormandie P, Gaillard JL, Perronne C. Outpatient parenteral antimicrobial therapy (OPAT) for the treatment of osteomyelitis: evaluation of efficacy, tolerance and cost. J Clin Pharm Ther. 2001 Dec;26(6):445-51. doi: 10.1046/j.1365-2710.2001.00380.x.
citation: Amodeo MR, Clulow T, Lainchbury J, Murdoch DR, Gallagher K, Dyer A, Metcalf SL, Pithie AD, Chambers ST. Outpatient intravenous treatment for infective endocarditis: safety, effectiveness and one-year outcomes. J Infect. 2009 Dec;59(6):387-93. doi: 10.1016/j.jinf.2009.09.009. Epub 2009 Sep 17.
citation: Durojaiye OC, Bell H, Andrews D, Ntziora F, Cartwright K. Clinical efficacy, cost analysis and patient acceptability of outpatient parenteral antibiotic therapy (OPAT): a decade of Sheffield (UK) OPAT service. Int J Antimicrob Agents. 2018 Jan;51(1):26-32. doi: 10.1016/j.ijantimicag.2017.03.016. Epub 2017 Jun 30.