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RecruitingNCT05458700Updated Sep 10, 2026

POS-cUTI: Study on Complicated Urinary Tract Infections

An observational study in Urinary Tract Infections, sponsored by European Clinical Research Alliance for Infectious Diseases (ECRAID). Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by European Clinical Research Alliance for Infectious Diseases (ECRAID) · Observational

From the registry’s dates

  • Started Oct 2022; still recruiting 4 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
16,000
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Urinary Tract Infections

Keywords

  • UTI
  • European clinical research network
  • Randomized ITUs research activities
03

In context

Urinary Tract Infections

803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.

This study's planned enrollment of 16,000 is above the median of 236 across 198 observational studies indexed under Urinary Tract Infections.

Browse Urinary Tract Infections studies →

Lead sponsor

European Clinical Research Alliance for Infectious Diseases (ECRAID) is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate or; notification of non-objection to the use of pseudo-anonymized personal and medical data.

Exclusion criteria

Exclusion Criteria:

  • Patients with a 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
16,000 participants (estimated)
Target follow-up
30 Days
Patient registry
Yes
Biospecimen retention
None retained

Interventions

  • OtherCollect information

    Collect information from the patients to support the design of innovate clinical trials

06

What researchers measure

Primary outcomes

  1. 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

    Clinical and microbiological cure at test of cure (TOC; 14-21 days ±3 days after the diagnosis of cUTI). Clinical cure is defined as the resolution of all new signs and symptoms related to cUTI and no need to continue with antibiotics; microbiological cure requires urine culture with \<103 CFU/mL of the initial pathogen. Whenever clinical and microbiological cure at TOC is not reached, it will be considered as failure.

    Time frame: 4 years

Secondary outcomes

  1. To describe the patient population with cUTI and the microbiological aetiology of cUTI in the study sites.

    Urine culture indicative of cUTI: performed/not, date, positive/negative, if positive: micoorganism, susceptibility. Date of susceptibility report

    Time frame: 4 years

  2. To determine the rate of recurrences and superinfections, and those caused by multidrugresistant organisms

    Recurrence of UTI (relapses and reinfections) in the first 30 days follow-up. Recurrence is defined as the reappearance of symptoms of urinary tract infection together with a positive blood culture or urine culture for the same microorganism isolated in the initial blood culture after having reached clinical and microbiological cure. Reinfection is defined in a similar way. Superinfections are other infections different from UTI. but with isolation of a bacteria or strain different from the initial one. Superinfections other infections different from UTI)

    Time frame: 4 years

  3. To determine the mortality and its predictors in patients with cUTI.

    All-cause 30-day mortality

    Time frame: 4 years

  4. To determine the length of hospital stay after cUTI

    Hospital stay after index cUTI episode in days.

    Time frame: 4 years

  5. To describe variations in current practices in treating cUTI in the study sites.

    Type of acquisition, urine culture indicative of cUTI, blood culture at days 0 and , location of cUTI, purulent complications, radiological and blood and urine test data, Pitt and SOFA scores, severity of systemic response, treatment of infection

    Time frame: 4 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05458700
Lead sponsor
European Clinical Research Alliance for Infectious Diseases (ECRAID)
Collaborators
UMC Utrecht, Hospital Universitario Virgen Macarena
Responsible party
Sponsor
First posted
Jul 14, 2022
Start date
Oct 10, 2022
Primary completion
Dec 1, 2026 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Elisa Moreno Mellado
Contact
elisamoreno500@hotmail.com
617245402
Pablo Martínez Aguado
Contact
pablo.martinez.aguado@juntadeandalucia.es
+34 606365362

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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