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

What Was Tested

The paper reports a study of Adrenomedullin, published as a randomized controlled trial.

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.

Why It Was Studied

Urinary tract infections (UTIs) are among the most common infectious diseases and drivers of antibiotic use and in-hospital days.

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.

Who Took Part

The study group was 300 patients.

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.

How the Study Was Run

The researchers set it up as a randomized and open-label study.

Random assignment meant chance, not the researchers, decided who got Adrenomedullin and who got the comparison, which limits bias.

Being open-label, the Adrenomedullin study did not mask who received what.

This randomized controlled open-label trial has a factorial design (2 × 2).

For their first Intervention (A), the researchers 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 their 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.

What Was Measured

Endpoints are assessed at discharge from hospital, and 30 and 90 days after admission.

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 subject headings attached to it are Adrenomedullin, Algorithms, Anti-Bacterial Agents, Biomarkers, Calcitonin, Calcitonin Gene-Related Peptide and Clinical Protocols.

What This Means in Plain Language

The paper is a randomized and open-label study of Adrenomedullin in 300 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

Its findings take up roughly 3 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2013 (Trials), a journal based in England.

More context: the Adrenomedullin compound page, all human trials.