POS-cUTI: Study on Complicated Urinary Tract Infections

POS-cUTI:Perpetual Observational 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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Other: Collect information

• Study Type: Observational
• Enrollment (Estimated): 16000

Contacts and Locations

• Study Contact: Name: Elisa Moreno Mellado; Phone Number: 617245402; Email: elisamoreno500@hotmail.com
• Study Contact Backup: Name: Pablo Martínez Aguado; Phone Number: +34 606365362; Email: pablo.martinez.aguado@juntadeandalucia.es

Study Locations

• Spain
  • Sevilla, Spain, 41009
    • Recruiting
    • Hospital Universitario Virgen Macarena
    • Contact: José Bravo-Ferrer Acosta, PI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 years
To determine the mortality and its predictors in patients with cUTI.	All-cause 30-day mortality	4 years
To determine the length of hospital stay after cUTI	Hospital stay after index cUTI episode in days.	4 years
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	4 years
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)	4 years

Collaborators and Investigators

• Sponsor: European Clinical Research Alliance for Infectious Diseases (ECRAID)
• Collaborators: UMC Utrecht; Hospital Universitario Virgen Macarena

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: UTI; European clinical research network; Randomized ITUs research activities
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: ECRAID-Base POS-cUTI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No