search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Point-of-care diagnostiek voor het vaststellen van urineweginfecties bij verpleeghuisbewoners


- candidate number27321
- NTR NumberNTR6467
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-mei-2017
- Secondary IDs50-54100-98-114 
- Public TitlePoint-of-care diagnostiek voor het vaststellen van urineweginfecties bij verpleeghuisbewoners
- Scientific TitlePoint-of-care diagnostics to guide appropriate antimicrobial therapy of urinary tract infections in nursing homes
- ACRONYMPROGRESS
- hypothesisPoint-of-Care (POC) diagnostic tests will support clinical rules for diagnosing Urinary Tract Infections (UTIs)
- Healt Condition(s) or Problem(s) studiedUrinary tract infections
- 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- Suspected respiratory tract infection OR suspected other infection requiring antibiotic therapy
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 11-sep-2017
- planned closingdate7-sep-2018
- Target number of participants600
- InterventionsC-Reactive Protein (CRP) and Procalcitonin (PCT) POC testing in nursing home residents clinically suspected of UTI.
- Primary outcomeSensitivity 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 outcomeAn 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.
- Timepoints10 days
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES S.D. Kuil
- CONTACT for SCIENTIFIC QUERIES C. Schneeberger
- Sponsor/Initiator Academic Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summaryRationale:
Nursing homes are increasingly regarded as an important reservoir for the emergence of antimicrobial resistance (AMR). Suspected urinary tract infections (UTI) rank among the most common reasons for antibiotic use in nursing homes. However diagnosing UTI in this setting is challenging because of frequent non-specific symptomatology combined with high prevalence of asymptomatic bacteriuria (ASB), which complicates attribution of causality detection of bacteria in urine. The difficulty of distinguishing true UTI from bacterial colonization of the urinary tract results in frequent inappropriate antibiotic use. In in this study, PROGRESS aims to evaluate the use of blood C-reactive protein (CRP) and procalcitonin (PCT) measurements to distinguish between bacteriuria and true infection in elderly nursing home residents with suspected UTI.

The PROGRESS study aims to evaluate the use of blood C-reactive protein (CRP) and procalcitonin (PCT) measurements to distinguish between bacteriuria and true infection in elderly nursing home residents with suspected UTI. A good marker for diagnosing a true UTI will help reducing antimicrobial resistance (AMR) in nursing homes by better informed decisions about who to treat.

Antimicrobial resistance (AMR) rates vary substantially between nursing homes. In this study the antimicrobial susceptibility data will be analysed to assess the usefulness of Lot Quality Assurance Sampling-based (LQAS) surveillance to generate relevant local ABR data to guide local empirical treatment. If successful, these combined approaches will reduce ABR in nursing homes by better informed decisions about who to treat and how.

Objective:
I.To assess the utility of point-of-care measurements of blood CRP and PCT levels to support clinical rules for diagnosing urinary tract infections UTI in nursing home residents.

II. To assess the usefulness of LQAS–based surveillance in providing relevant AMR prevalence data to guide local empirical treatment choices in nursing homes.

III. To develop and assess strategies that facilitate implementation of point-of-care testing in nursing homes.

Study design:
12-month matched diagnostic accuracy study in several nursing homes of the University Network for Organisations of Elderly care of the VU University Medical Center (UNO-VUmc). The matching refers to the assessment of blood CRP and PCT levels simultaneously in the same study participants.

Study population:
Nursing home residents with suspected UTI based on current clinical rules.

Main study parameters/endpoints:
For part I: Sensitivity of the POC tests to identify patients with true UTIs
For part II: an LQAS-classification into high versus low AMR prevalence using pre-defined thresholds. Different thresholds for high and low prevalence will be tested
For part III Barriers and facilitators for the adoption and implementation of the POC-test in nursing homes
- Main changes (audit trail)
- RECORD25-mei-2017 - 3-jul-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl