Procalcitonin, pyuria and proadrenomedullin in the management of Urinary Tract Infections - the 'Triple P in UTI' study: Optimal patient transfer in the canton of Argovia [Optimaler Patiententransfer im Kanton Aaragau] (OPTIMA III)

Not Applicable

Completed

• Conditions: rinary Tract Infection (UTI); Urological and Genital Diseases; Urinary tract infection, site not specified

• Registration Number: ISRCTN13663741
• Lead Sponsor: Kantonsspital Aarau (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-03
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Patients 18 years of age or older
2. Admitted from the community or a nursing home with acute (i.e. symptoms less than 28 days) UTI as one main diagnosis based on at least one clinical symptom (core body temperature >= 38.0° C, urgency, frequency of micturition, dysuria, suprapubic pain, flank pain, costovertebral angle tenderness, nausea and vomiting)
3. One urinary criterion (pyuria (>20 leukocytes/µl), and/or nitrites) in patients without antibiotic pretreatment. If the initial and final diagnoses are discrepant, the patient will be classified according to the final diagnosis. If the final diagnosis is different from an UTI, the patient will be classified as ?others?.
4. Ability to understand verbal and written instructions and informed consent by patient or available relatives. If both the patient is unable to provide informed consent (e.g. dementia, coma) and there are no relatives available, an independent physician, who is not involved in the trial, may provide the informed consent based on the presumed will of the patient.

Exclusion Criteria

1. Pregnancy
2. Immundeficiency (neutrophiles <500/ìL; if HIV+: CD4<350/ìL, leukemia, lymphoma, myeloma, cytotoxic medications, hemodialysis, transplant patients)
3. Prostatitis (i.e. increased PSA-level >4, or PSA more than double of a pre-existing baseline level, or pain on palpation)
4. Implanted foreign bodies in the urinary tract or urinary catheters
5. Patients with endovascular prostheses or foreign bodies
6. Patients with non-endovascular prostheses or foreign bodies within 6 months after implantation
7. Pre-treatment with antibiotics within the last 48 hours
8. Patients without command of the German (or other local) language, who will not be able within reason to get translation (e.g. family members) during admission, hospitalization and follow-up telephone interview
9. Terminal and very severe disease or medical co-morbidity where death is imminent and comfort therapy is provided
10. Foreseeable non-compliance for follow-up (e.g. current drug abuse)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Duration of antibiotic therapy (Antibiotic therapy study)<br>2. Physician-led length of stay during the index hospital exposure (triage study)