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Open Access Study protocol

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

Daniel Drozdov1, Anja Thomer1, Marc Meili1, Stefanie Schwarz1, Rita Bossart Kouegbe1, Katharina Regez1, Merih Guglielmetti1, Ursula Schild1, Antoinette Conca4, Petra Schäfer4, Barbara Reutlinger4, Cornelia Ottiger6, Florian Buchkremer3, Alexander Litke1, Philipp Schuetz1, Andreas Huber6, Ulrich Bürgi5, Christoph A Fux2, Andreas Bock3, Beat Müller1, Werner C Albrich7* and the Triple P study group

Author Affiliations

1 Medical University Department, University of Basel, Kantonsspital Aarau, Tellstrasse, Aarau, 5001, Switzerland

2 Division of Infectious Diseases, Kantonsspital Aarau, Tellstrasse, Aarau, 5001, Switzerland

3 Division of Nephrology, Kantonsspital Aarau, Tellstrasse, Aarau, 5001, Switzerland

4 Department of Clinical Nursing Science, Kantonsspital Aarau, Tellstrasse, Aarau, 5001, Switzerland

5 Department of Emergency Medicine, Kantonsspital Aarau, Tellstrasse, Aarau, 5001, Switzerland

6 Department of Laboratory Medicine, Kantonsspital Aarau, Tellstrasse, Aarau, 5001, Switzerland

7 Department of Infectious Diseases, Kantonsspital St Gallen, Rorschacher Strasse 95, St Gallen, 9007, Switzerland

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Trials 2013, 14:84  doi:10.1186/1745-6215-14-84

Published: 22 March 2013

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