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Published in: Trials 1/2013

Open Access 01-12-2013 | Study protocol

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

Authors: Daniel Drozdov, Anja Thomer, Marc Meili, Stefanie Schwarz, Rita Bossart Kouegbe, Katharina Regez, Merih Guglielmetti, Ursula Schild, Antoinette Conca, Petra Schäfer, Barbara Reutlinger, Cornelia Ottiger, Florian Buchkremer, Alexander Litke, Philipp Schuetz, Andreas Huber, Ulrich Bürgi, Christoph A Fux, Andreas Bock, Beat Müller, Werner C Albrich, the Triple P study group

Published in: Trials | Issue 1/2013

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Abstract

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
Appendix
Available only for authorised users
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Metadata
Title
Procalcitonin, pyuria and proadrenomedullin in the management of urinary tract infections – ‘triple p in uti’: study protocol for a randomized controlled trial
Authors
Daniel Drozdov
Anja Thomer
Marc Meili
Stefanie Schwarz
Rita Bossart Kouegbe
Katharina Regez
Merih Guglielmetti
Ursula Schild
Antoinette Conca
Petra Schäfer
Barbara Reutlinger
Cornelia Ottiger
Florian Buchkremer
Alexander Litke
Philipp Schuetz
Andreas Huber
Ulrich Bürgi
Christoph A Fux
Andreas Bock
Beat Müller
Werner C Albrich
the Triple P study group
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-84

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