Point-of-care testen van CRP en procalcitonine bij urineweginfecties in verpleeghuizen

Point-of-care diagnostics to guide appropriate antimicrobial therapy of urinary tract infections in nursing homes

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27528

Enrollment

440

Registered

2017-05-25

Start date

2017-09-11

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary tract infection Urineweginfectie

Interventions

C-Reactive Protein (CRP) and Procalcitonin (PCT) POC testing in nursing home residents clinically suspected of UTI.

Eligibility

Inclusion criteria

Inclusion criteria: - Nursing homes residents clinically suspected of a urinary tract infection at the discretion of the attending physician - Provided pre-emptive informed consent

Exclusion criteria

Exclusion criteria: - Suspected respiratory tract infection OR suspected other infection requiring antibiotic therapy - Previous inclusion in the past 30 days

Design outcomes

Primary

Measure	Time frame
Sensitivity of the point-of-care (POC) test to identify patients with true UTIs, as derived from Receiving Operating Curves (ROC). As there is no uniform definition of an UTI, a ‘true UTI’ is defined post-hoc using stringent criteria, including microbiology results and clinical response to adequate antibiotic therapy. The following definition is defined: 1.Presence of at least 2 urinary (dysuria, urgency or frequency, new or worsened incontinence, suprapubic or costovertabral angle tenderness) OR non-specific (fever, confusion, delirium, anorexia, malaise) symptoms; AND 2.Positive urine leucocyte esterase tests AND 3.The presence of a uropathogen in urine at >10E4 CFU/mL (maximum of 2 uropathogens) AND 4.Symptom resolution in the course of adequate antibiotic treatment, where adequate treatment is defined by proven susceptibility of isolated uropathogens to the administered antibiotic.	—

Measure

Time frame

Sensitivity of the point-of-care (POC) test to identify patients with true UTIs, as derived from Receiving Operating Curves (ROC). As there is no uniform definition of an UTI, a ‘true UTI’ is defined post-hoc using stringent criteria, including microbiology results and clinical response to adequate antibiotic therapy. The following definition is defined: 1.Presence of at least 2 urinary (dysuria, urgency or frequency, new or worsened incontinence, suprapubic or costovertabral angle tenderness) OR non-specific (fever, confusion, delirium, anorexia, malaise) symptoms; AND 2.Positive urine leucocyte esterase tests AND 3.The presence of a uropathogen in urine at >10E4 CFU/mL (maximum of 2 uropathogens) AND 4.Symptom resolution in the course of adequate antibiotic treatment, where adequate treatment is defined by proven susceptibility of isolated uropathogens to the administered antibiotic.

—

Secondary

Measure	Time frame
An LQAS-classification into high versus low AMR prevalence using pre-defined thresholds. Different thresholds for high and low prevalence will be tested Barriers and facilitators for the adoption and implementation of the POC-test.	—

Contacts

Public ContactS.D. Kuil

AmsterdamUMC location AMC

s.d.kuil@amc.nl0622351829

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)