POS-cUTI: Study on Complicated Urinary Tract Infections

NCT05458700 | Recruiting DMC

• 1 other identifier: ECRAID-Base POS-cUTI
• Study Type: observational
• Target: 16,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Keywords

UTI; European clinical research network; Randomized ITUs research activities

Outcome Measures

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.

  4 years

Secondary Outcomes (5)

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

  4 years

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

  4 years

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

  4 years

• To determine the length of hospital stay after cUTI

  4 years

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

  4 years

Interventions

Collect information OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Clinical Research Alliance for Infectious Diseases (ECRAID): lead
• UMC Utrecht: collaborator
• Hospital Universitario Virgen Macarena: collaborator

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Biospecimen

Retention: NONE RETAINED

Urine culture, blood culture

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Elisa Moreno Mellado

CONTACT

617245402; elisamoreno500@hotmail.com

Pablo Martínez Aguado

CONTACT

+34 606365362; pablo.martinez.aguado@juntadeandalucia.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: July 14, 2022
• Study Start: October 10, 2022
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)