Clinical trial NCT05458700: POS-cUTI: Study on Complicated Urinary Tract Infections
Official title: POS-cUTI:Perpetual Observational Study on Complicated Urinary Tract Infections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Tract Infections
Keywords: UTI
European clinical research network
Randomized ITUs research activities
Lead sponsor: European Clinical Research Alliance for Infectious Diseases (ECRAID)
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
name: Hospital Universitario Virgen Macarena
First posted: 2022-07-14
Enrollment: 16000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (≥18 years) patients admitted to an acute care hospital with cUTI, or developing cUTI during hospital stay

Brief summary: Urinary tract infections (UTI) are among the most common infectious diseases and the most frequent source of community, healthcare-associated and nosocomial bacteraemia. They are associated with significant morbidity and mortality. Due to the high frequency of UTI, they have a major impact on antibiotic use and the antimicrobial resistance of prominent UTI pathogens is of recognised importance. Therefore, UTIs, and particularly complicated urinary tract infections cUTIs, are a target for repurposing of old and neglected drugs, new drug development and non-antibiotic therapeutic and preventive approaches.


Eligibility criteria: Inclusion Criteria:

* A documented microbial pathogen on culture of blood OR urine according to standards of interpretation regarding to the type of infection, pathogen, quantitative culture results and sample. Guide for adequate interpretation is detailed in Lab Manual. However, if the local laboratory uses diferent microbiological criteria, patients will be elegible and the criteria used will be collected AND
* Local and systemic signs and symptoms of UTI including at least one of these two: (a) fever (i.e.,temperature greater than 38ºC), chills or malaise; and (b) flank pain, back pain, costo-vertebral angle pain or tenderness, dysuria or urinary urgency, AND
* It occurs in the presence of a functional or anatomical abnormality of the urinary tract or in the presence of catheterization, including (but not limited to) presence of a urinary catheter; 100 mL or more of residual urine after voiding (neurogenic bladder); obstructive uropathy (nephrolithiasis, fibrosis); azotemia caused by intrinsic renal disease; urinary retention, including retention caused by benign prostatic hypertrophy.
* Patients with pyelonephritis or bacteremia with a urinary tract source, regardless of underlying abnormalities of the urinary tract, are also to be included.
* Patients with urinary catheter presenting with fever, bacteriuria and bacteraemia caused by the same urinary pathogen can be included if other sources of bacteraemia are reasonably discarded.
* Depending on the country regulation: The patient, family or legally authorised representative signed the informed consent to participate or; notification of non-objection to the use of pseudo-anonymized personal and medical data.

Exclusion Criteria:

* Patients with a life expectancy previous to development of cUTI \<30 days and those exclusively under palliative care in whom any eventually needed invasive procedure would not be performed.
* Patients who died in \<48 hours since the presentation with cUTI
* Patients participating in RCT for treatment of cUTI
* \>96 hours since from the clinical diagnosis of cUTI. I.e. \>96 hours from positive urine/blood culture.

Primary outcomes:
measure: To delineate the outcomes of patients with cUTI, and the impact of managemnt-related variables; specifically the incidence of treatment failure in patients with cUTI and modifiable and non-modifiable risk factors for treatment failure
timeFrame: 4 years
Secondary outcomes:
measure: To describe the patient population with cUTI and the microbiological aetiology of cUTI in the study sites.
timeFrame: 4 years
measure: To determine the rate of recurrences and superinfections, and those caused by multidrugresistant organisms
timeFrame: 4 years
measure: To determine the mortality and its predictors in patients with cUTI.
timeFrame: 4 years
measure: To determine the length of hospital stay after cUTI
timeFrame: 4 years
measure: To describe variations in current practices in treating cUTI in the study sites.
timeFrame: 4 years
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
References: