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Procalcitonin, pyuria and proadrenomedullin in the management of urinary tract infections – ‘triple p in uti’: study protocol for a randomized controlled trial

BACKGROUND: Urinary tract infections (UTIs) are among the most common infectious diseases and drivers of antibiotic use and in-hospital days. A reduction of antibiotic use potentially lowers the risk of antibiotic resistance. An early and adequate risk assessment combining medical, biopsychosocial a...

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Autores principales: Drozdov, Daniel, Thomer, Anja, Meili, Marc, Schwarz, Stefanie, Kouegbe, Rita Bossart, Regez, Katharina, Guglielmetti, Merih, Schild, Ursula, Conca, Antoinette, Schäfer, Petra, Reutlinger, Barbara, Ottiger, Cornelia, Buchkremer, Florian, Litke, Alexander, Schuetz, Philipp, Huber, Andreas, Bürgi, Ulrich, Fux, Christoph A, Bock, Andreas, Müller, Beat, Albrich, Werner C
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3614534/
https://www.ncbi.nlm.nih.gov/pubmed/23522152
http://dx.doi.org/10.1186/1745-6215-14-84
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author Drozdov, Daniel
Thomer, Anja
Meili, Marc
Schwarz, Stefanie
Kouegbe, Rita Bossart
Regez, Katharina
Guglielmetti, Merih
Schild, Ursula
Conca, Antoinette
Schäfer, Petra
Reutlinger, Barbara
Ottiger, Cornelia
Buchkremer, Florian
Litke, Alexander
Schuetz, Philipp
Huber, Andreas
Bürgi, Ulrich
Fux, Christoph A
Bock, Andreas
Müller, Beat
Albrich, Werner C
author_facet Drozdov, Daniel
Thomer, Anja
Meili, Marc
Schwarz, Stefanie
Kouegbe, Rita Bossart
Regez, Katharina
Guglielmetti, Merih
Schild, Ursula
Conca, Antoinette
Schäfer, Petra
Reutlinger, Barbara
Ottiger, Cornelia
Buchkremer, Florian
Litke, Alexander
Schuetz, Philipp
Huber, Andreas
Bürgi, Ulrich
Fux, Christoph A
Bock, Andreas
Müller, Beat
Albrich, Werner C
author_sort Drozdov, Daniel
collection PubMed
description BACKGROUND: Urinary tract infections (UTIs) are among the most common infectious diseases and drivers of antibiotic use and in-hospital days. A reduction of antibiotic use potentially lowers the risk of antibiotic resistance. An early and adequate risk assessment combining medical, biopsychosocial and functional risk scores has the potential to optimize site-of-care decisions and thus allocation of limited health-care resources. The aim of this factorial design study is twofold: first, for Intervention A, it investigates antibiotic exposure of patients treated with a protocol based on the type of UTI, procalcitonin (PCT) and pyuria. Second, for Intervention B, it investigates the usefulness of the prognostic biomarker proadrenomedullin (ProADM) integrated into an interdisciplinary assessment bundle for site-of-care decisions. METHODS AND DESIGN: This randomized controlled open-label trial has a factorial design (2 × 2). Randomization of patients will be based on a pre-specified computer-generated randomization list and independent for the two interventions. Adults with UTI presenting to the emergency department (ED) will be screened and enrolled after providing informed consent. For our first Intervention (A), we developed a protocol based on previous observational research to recommend initiation and duration of antibiotic use based on the clinical presentation of UTI, pyuria and PCT levels. For our second intervention (B), an algorithm was developed to support site-of care decisions based on the prognostic marker ProADM and distinct nursing factors on days 1 and 3. Both interventions will be compared with a control group conforming to the guidelines. The primary endpoints for the two interventions will be: (A) overall exposure to antibiotics and (B) length of physician-led hospitalization within a follow-up of 30 days. Endpoints are assessed at discharge from hospital, and 30 and 90 days after admission. We plan to screen 300 patients and enroll 250 for an anticipated estimated loss of follow-up of 20%. This will provide adequate power for the two interventions. DISCUSSION: This trial investigates two strategies for improved individualized medical care in patients with UTI. The minimally effective duration of antibiotic therapy is not known for UTIs, which is important for reducing the selection pressure for antibiotic resistance, costs and drug-related side effects. Triage decisions must be improved to reflect the true medical, biopsychosocial and functional risks in order to allocate patients to the most appropriate care setting and reduce hospital-acquired disability. TRIAL REGISTRATION: Trial registration number: ISRCTN13663741
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spelling pubmed-36145342013-04-03 Procalcitonin, pyuria and proadrenomedullin in the management of urinary tract infections – ‘triple p in uti’: study protocol for a randomized controlled trial Drozdov, Daniel Thomer, Anja Meili, Marc Schwarz, Stefanie Kouegbe, Rita Bossart Regez, Katharina Guglielmetti, Merih Schild, Ursula Conca, Antoinette Schäfer, Petra Reutlinger, Barbara Ottiger, Cornelia Buchkremer, Florian Litke, Alexander Schuetz, Philipp Huber, Andreas Bürgi, Ulrich Fux, Christoph A Bock, Andreas Müller, Beat Albrich, Werner C Trials Study Protocol BACKGROUND: Urinary tract infections (UTIs) are among the most common infectious diseases and drivers of antibiotic use and in-hospital days. A reduction of antibiotic use potentially lowers the risk of antibiotic resistance. An early and adequate risk assessment combining medical, biopsychosocial and functional risk scores has the potential to optimize site-of-care decisions and thus allocation of limited health-care resources. The aim of this factorial design study is twofold: first, for Intervention A, it investigates antibiotic exposure of patients treated with a protocol based on the type of UTI, procalcitonin (PCT) and pyuria. Second, for Intervention B, it investigates the usefulness of the prognostic biomarker proadrenomedullin (ProADM) integrated into an interdisciplinary assessment bundle for site-of-care decisions. METHODS AND DESIGN: This randomized controlled open-label trial has a factorial design (2 × 2). Randomization of patients will be based on a pre-specified computer-generated randomization list and independent for the two interventions. Adults with UTI presenting to the emergency department (ED) will be screened and enrolled after providing informed consent. For our first Intervention (A), we developed a protocol based on previous observational research to recommend initiation and duration of antibiotic use based on the clinical presentation of UTI, pyuria and PCT levels. For our second intervention (B), an algorithm was developed to support site-of care decisions based on the prognostic marker ProADM and distinct nursing factors on days 1 and 3. Both interventions will be compared with a control group conforming to the guidelines. The primary endpoints for the two interventions will be: (A) overall exposure to antibiotics and (B) length of physician-led hospitalization within a follow-up of 30 days. Endpoints are assessed at discharge from hospital, and 30 and 90 days after admission. We plan to screen 300 patients and enroll 250 for an anticipated estimated loss of follow-up of 20%. This will provide adequate power for the two interventions. DISCUSSION: This trial investigates two strategies for improved individualized medical care in patients with UTI. The minimally effective duration of antibiotic therapy is not known for UTIs, which is important for reducing the selection pressure for antibiotic resistance, costs and drug-related side effects. Triage decisions must be improved to reflect the true medical, biopsychosocial and functional risks in order to allocate patients to the most appropriate care setting and reduce hospital-acquired disability. TRIAL REGISTRATION: Trial registration number: ISRCTN13663741 BioMed Central 2013-03-22 /pmc/articles/PMC3614534/ /pubmed/23522152 http://dx.doi.org/10.1186/1745-6215-14-84 Text en Copyright © 2013 Drozdov et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Drozdov, Daniel
Thomer, Anja
Meili, Marc
Schwarz, Stefanie
Kouegbe, Rita Bossart
Regez, Katharina
Guglielmetti, Merih
Schild, Ursula
Conca, Antoinette
Schäfer, Petra
Reutlinger, Barbara
Ottiger, Cornelia
Buchkremer, Florian
Litke, Alexander
Schuetz, Philipp
Huber, Andreas
Bürgi, Ulrich
Fux, Christoph A
Bock, Andreas
Müller, Beat
Albrich, Werner C
Procalcitonin, pyuria and proadrenomedullin in the management of urinary tract infections – ‘triple p in uti’: study protocol for a randomized controlled trial
title Procalcitonin, pyuria and proadrenomedullin in the management of urinary tract infections – ‘triple p in uti’: study protocol for a randomized controlled trial
title_full Procalcitonin, pyuria and proadrenomedullin in the management of urinary tract infections – ‘triple p in uti’: study protocol for a randomized controlled trial
title_fullStr Procalcitonin, pyuria and proadrenomedullin in the management of urinary tract infections – ‘triple p in uti’: study protocol for a randomized controlled trial
title_full_unstemmed Procalcitonin, pyuria and proadrenomedullin in the management of urinary tract infections – ‘triple p in uti’: study protocol for a randomized controlled trial
title_short Procalcitonin, pyuria and proadrenomedullin in the management of urinary tract infections – ‘triple p in uti’: study protocol for a randomized controlled trial
title_sort procalcitonin, pyuria and proadrenomedullin in the management of urinary tract infections – ‘triple p in uti’: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3614534/
https://www.ncbi.nlm.nih.gov/pubmed/23522152
http://dx.doi.org/10.1186/1745-6215-14-84
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