Urinary Tract InfectionsNCT05458700
POS-cUTI: Study on Complicated Urinary Tract Infections
An observational study of Urinary Tract Infections, run by European Clinical Research Alliance for Infectious Diseases (ECRAID) at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Collect information
- How many people
- 16,000 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2022to 1 Mar 2027
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (≥18 years) patients admitted to an acute care hospital with cUTI, or developing cUTI during hospital stay
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen Macarena
Seville, Sevilla, 41009
José Bravo-Ferrer Acosta, PI
About this study
Official title: 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.
- Conditions
- Urinary Tract Infections
- Being tested
- Collect information
- Keywords
- UTI, European clinical research network, Randomized ITUs research activities
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect informationOther
Collect information from the patients to support the design of innovate clinical trials
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (5)
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
Measured: 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)
Measured: 4 years
To determine the mortality and its predictors in patients with cUTI.
All-cause 30-day mortality
Measured: 4 years
To determine the length of hospital stay after cUTI
Hospital stay after index cUTI episode in days.
Measured: 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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start10 Oct 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- European Clinical Research Alliance for Infectious Diseases (ECRAID)
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, Hospital Universitario Virgen Macarena
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458700
- Sponsor's protocol ID
- ECRAID-Base POS-cUTI
- Status last verified
- Sep 2026
- First submitted
- 20 May 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POS-cUTI:Perpetual Observational Study on Complicated Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT05458700
- Acronym / sponsor ID
- ECRAID-Base POS-cUTI
- Conditions
- Urinary Tract Infections
- Keywords
- UTI, European clinical research network, Randomized ITUs research activities
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- European Clinical Research Alliance for Infectious Diseases (ECRAID)University, hospital or other
- Collaborators
- UMC Utrecht, Hospital Universitario Virgen Macarena
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (≥18 years) patients admitted to an acute care hospital with cUTI, or developing cUTI during hospital stay
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collect informationCollect information from the patients to support the design of innovate clinical trials | Other | – |
Primary outcome
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.
5 secondary outcomes
To describe the patient population with cUTI and the microbiological aetiology of cUTI in the study sites.
Time frame: 4 years
To determine the rate of recurrences and superinfections, and those caused by multidrugresistant organisms
Time frame: 4 years
To determine the mortality and its predictors in patients with cUTI.
Time frame: 4 years
To determine the length of hospital stay after cUTI
Time frame: 4 years
To describe variations in current practices in treating cUTI in the study sites.
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by European Clinical Research Alliance for Infectious Diseases (ECRAID) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisa Moreno Mellado (617245402, elisamoreno500@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.