POS-cUTI: Study on Complicated Urinary Tract Infections

Recruiting

• Conditions: Urinary Tract Infections

• Registration Number: NCT05458700
• Lead Sponsor: European Clinical Research Alliance for Infectious Diseases (ECRAID)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-07-12
• Study First Posted: 2022-07-14
• Study Start: 2022-10-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-21
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
To describe the patient population with cUTI and the microbiological aetiology of cUTI in the study sites.	4 years	Urine culture indicative of cUTI: performed/not, date, positive/negative, if positive: micoorganism, susceptibility. Date of susceptibility report
To determine the rate of recurrences and superinfections, and those caused by multidrugresistant organisms	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)
To describe variations in current practices in treating cUTI in the study sites.	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
To determine the mortality and its predictors in patients with cUTI.	4 years	All-cause 30-day mortality
To determine the length of hospital stay after cUTI	4 years	Hospital stay after index cUTI episode in days.

Trial Locations

Locations (1)

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain