Implementation of an Outpatient Parenteral Antimicrobial Therapy Program
NCT ID: NCT05707507
Last Updated: 2023-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2023-02-01
2024-01-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Outpatient antimicrobial therapy
Included patients will receive outpatient antimicrobial therapy according to their infectious disease.
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.
Inpatient antimicrobial therapy
Included patients will receive intrahospital antimicrobial therapy according to their infectious disease.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Need to be treated for 3 or more days
* Suitable catheter/venous access
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hospital Universitario Dr. Jose E. Gonzalez
OTHER
Responsible Party
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Dr. Adrian Camacho-Ortiz
Head of Infectious Diseases Department
Locations
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Hospital Universitario José E. Gonzalez
Monterrey, Nuevo León, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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IF22-00011
Identifier Type: -
Identifier Source: org_study_id
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