Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05458700

POS-cUTI: Study on Complicated Urinary Tract Infections

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Virgen Macarena

Seville, Sevilla, 41009, Spain

Location status: Recruiting

Location contact

José Bravo-Ferrer Acosta, PI

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collect information

Other

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

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

    Time frame: 4 years

    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.

Secondary outcomes

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

    Time frame: 4 years

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

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

    Time frame: 4 years

    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)

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

    Time frame: 4 years

    All-cause 30-day mortality

  4. To determine the length of hospital stay after cUTI

    Time frame: 4 years

    Hospital stay after index cUTI episode in days.

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

    Time frame: 4 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Elisa Moreno Mellado

CONTACT

[email protected]

617245402

Pablo Martínez Aguado

CONTACT

[email protected]

+34 606365362

Sponsors and collaborators

Lead sponsor

European Clinical Research Alliance for Infectious Diseases (ECRAID)

Other

Collaborators

  • Hospital Universitario Virgen Macarena
  • UMC Utrecht

Registry information

Official study title

POS-cUTI:Perpetual Observational Study on Complicated Urinary Tract Infections

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jul 14, 2022
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.