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 develop and assess strategies that facilitate implementation of…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For part I: Sensitivity of the POC tests to identify patients with true UTIs
For part II Barriers and facilitators for the adoption and implementation of
the POC-test in nursing homes
Secondary outcome
N/a
Background summary
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.
Study 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 develop and assess strategies that facilitate implementation of
point-of-care testing in nursing homes.
Study design
2 year 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 burden and risks
Group relatedness
The nature of the setting is one of the main reasons for this study, since
diagnosing UTI in elderly nursing home residents is challenging because of
frequent non-specific symptomatology. Part of the patients will be
incapacitated, one of the reasons diagnosing UTI is complicated in this
population. Moreover, inflammatory markers such as CRP or PCT behave
differently with ageing and frailty, which emphasizes the need for research in
this specific population.
Burden and risks
For this study a blood and urine sample are needed and medical information from
the patient record will be extracted. Blood sample collection will be carried
out by a trained doctor or (study) nurse. Collection of a single urine sample
and single blood sample are both considered minimal invasive research
procedures and are often performed as part of routine care. Therefore we argue
that risk for both procedures is minimal. To further minimize the burden for
the participants, we will make use of the participants daily routine for blood
and urine sample collection. Collection methods will be determined with the
participants and caretakers, depending on personal factors such as urine
incontinence.
In the case of a legally incapacitated patient, any form of objection against
participation, will result in ending the testing procedure. Patients will be
diagnosed and treated following local guidelines.
Benefit
The patients will not directly benefit from this study because both the results
of the blood sample (used for CRP and procalcitonin) and the urine sample (used
for nitrite and leukocytes dipstick and urine culture) will not be reported to
the patient or treating physician. Because the aim of this study is to assess
the utility of CRP and PCT as POC-tests, we cannot report the results in this
part of the PROGRESS study. Patient will receive care as usual.
Meibergdreef 9 Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9 Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Nursing home residents clinically suspected of a urinary tract infection
Exclusion criteria
Suspected respiratory tract infection OR suspected other infection requiring
antibiotic therapy
Previous inclusion in the past 30 days.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL62067.029.17 |
OMON | NL-OMON27528 |