POS-cUTI: Study on Complicated Urinary Tract Infections

Launched by EUROPEAN CLINICAL RESEARCH ALLIANCE FOR INFECTIOUS DISEASES (ECRAID) · Jul 12, 2022

Keywords

ClinConnect Summary

The POS-cUTI clinical trial is studying complicated urinary tract infections (cUTIs), which are serious infections that can occur when there are issues with the urinary system. These infections are quite common and can lead to significant health problems, especially in people who have certain underlying conditions. The goal of this study is to explore new treatment options, including using older drugs in new ways and other non-antibiotic approaches to help fight these infections.

To participate in the trial, individuals must be between the ages of 65 and 74 and have a confirmed urinary tract infection, indicated by specific symptoms such as fever or pain, and must have certain medical conditions that affect the urinary tract, like having a urinary catheter or other anatomical issues. Participants will undergo tests to confirm their condition and will work closely with the research team. It’s also important to know that the trial is currently recruiting participants, and informed consent will be required before joining. If you or someone you know fits the eligibility criteria and is interested, discussing this with a healthcare provider can be a great next step.

Gender

ALL

Eligibility criteria

• 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.