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| Name | Class |
|---|---|
| UMC Utrecht | OTHER |
| Hospital Universitario Virgen Macarena | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collect information | Other | Collect information from the patients to support the design of innovate clinical trials |
| 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 |
| 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 rate of recurrences and superinfections, and those caused by multidrugresistant organisms |
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Inclusion Criteria:
Exclusion Criteria:
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Adult (≥18 years) patients admitted to an acute care hospital with cUTI, or developing cUTI during hospital stay
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisa Moreno Mellado | Contact | 617245402 | elisamoreno500@hotmail.com | |
| Pablo MartÃnez Aguado | Contact | +34 606365362 | pablo.martinez.aguado@juntadeandalucia.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen Macarena | Recruiting | Seville | 41009 | Spain |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Urine culture, blood culture
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 |
| 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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |