Establish relevance of a clinical scoring system, and of established and to be identified biomarkers in blood and urine for clinical course and clinical and microbiological outcome of patients with a complicated urinary tract infection, treated in…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical cure (resolution of symptoms; determined by diary and follow up after
one and three months) and microbiological cure (negative urine culture) after
one month. Duration of fever, hospital and/or ICU stay, and outcome, both with
respect to course of disease (fever days, development of circulatory shock,
multiple organ dysfunction, need of stay in ICU stay and/or urological
intervention, number of sick days) as well as recovery or death.
Secondary outcome
Course of microbiological and host-derived biomarkers in urine and serum,
assessed by massspectrometry.
Background summary
For patients with pneumonia the risk of complications contributing to an
adverse outcome, i.e., death, can be reliably estimated by means of a set of
clinical criteria. If the risk estimator is small a patient may be treated at
home with oral antibiotics, if the risk estimator is high hospital admission is
advised. For complicated urinary tract infections a set of clinical criteria
have not been established.
Study objective
Establish relevance of a clinical scoring system, and of established and to be
identified biomarkers in blood and urine for clinical course and clinical and
microbiological outcome of patients with a complicated urinary tract infection,
treated in primary care by their general practitioner, admitted to hospital
and/or transferred to ICunit.
Study design
A prospective, observational, non-interventional multi-center cohort study.
Study burden and risks
Patients receive standard treatment for urinary tract infection, as put forward
by the Dutch GP association 2005.
The burden of study procedures is minimal.
Blood is taken on day 0 and day 3 in patients enrolled by GPs.
In hospitalized patients, this blood sampling is combined with standard
venapunctures, preluding additional procedures.
The risk of the study is minimal, the venapunctures will be conducted by
qualified personnel.
Albinusdreef 2
2333 ZA Leiden
Nederland
Albinusdreef 2
2333 ZA Leiden
Nederland
Listed location countries
Age
Inclusion criteria
- at least one symptom suggestive of urinary tract infection , and
- fever, and
- positive urine nitrate test or
- positive leukocyte esterase test
Exclusion criteria
- polycystic kidney disease
- end-stage renal failure
- renal transplant
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL11811.058.06 |