Relevance of Biomarkers and Clinical Predictors of Outcome in Unselected Population with Febrile Urinary Tract Infection at Primary Care and Emergency Department in a Prospective, Randomized Cohort Trial Comparing Short (7 days) Antibiotic Treatment with Conventional Treatment (14 days) - FUTIRST (Febrile Urinary Tract Infection Randomized Short Treatment)

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001081-80-NL

Enrollment

500

Registered

2008-03-06

Start date

2008-06-20

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To determine whether a 7-day duration of antibiotic treatment is non inferior to 14-day standard duration of treatment in adults presenting at primary care or emergency department with febrile urinary tract infection.

Interventions

Trade Name: ciprofloxacin Product Name: ciprofloxacin Pharmaceutical Form: Coated tablet CAS Number: 86393320 Other descriptive name: CIPROFLOXACIN MONOHYDROCHLORIDE MONOHYDRATE Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Competent patient aged 18 years or above 2. One or more symptom(s) suggestive of urinary tract infection (dysuria, frequency or urgency*; perineal or suprapubic pain; costo-vertebral tenderness or flank pain) 3. Fever (ear or rectal temp of 38.2 oC or higher, or axillary temp of 38 oC or higher), or history of feeling feverish with shivering or rigors in the past 24 hours 4. Positive urine nitrate test and/or leucocyturia as depicted by positive leukocyte esterase test or microscopy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Known allergy to fluoroquinolones 2. Female patients who are pregnant or lactating 3. Patients with known polycystic kidney disease 4. Patients on permanent renal replacememt therapy (hemodialysis or peritoneal dialysis) 5. Patients with history of kidney transplantation 6. Residence outside country of enrolment 7. Inability to speak or read Dutch

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether a 7-day duration of antibiotic treatment is non inferior to 14-day standard duration of treatment in adult patients presenting at primary care or emergency department with febrile urinary tract infection;Secondary Objective: The assessment of clinical parameters and biomarkers in blood and urine of adult patients presenting at primary care or emergency department with febrile urinary tract infection, in predicting bacteremia, need for hospital admission, clinical and bacteriologic cure and mortality an d to determine the prevalence of pelvic floor dysfunction and the occurrence of Clostridium Difficile associated diarrhea;Primary end point(s): The primary outcome measure is clinical cure rate (i.e., resolution of symptoms and fever) among evaluable patients through the 10- to 18-day posttherapy visit. Evaluable patients for Intention-to-Treat analysis are those who met the following criteria: (1) enrollment criteria of febrile urinary tract infection, (2) received at least one dose of study drugs and (3) follow-up visit. Evaluable patients for Per-Protocol analysis are those who met the following criteria: (1) enrollment criteria of febrile urinary tract infection, (2) received the study drug for a minimum of 24 hours (in case of treatment failure) or received at least 80% of the study drug (in case of clinical cure) and (3) follow-up visit.	—

Measure

Time frame

Main Objective: To determine whether a 7-day duration of antibiotic treatment is non inferior to 14-day standard duration of treatment in adult patients presenting at primary care or emergency department with febrile urinary tract infection;Secondary Objective: The assessment of clinical parameters and biomarkers in blood and urine of adult patients presenting at primary care or emergency department with febrile urinary tract infection, in predicting bacteremia, need for hospital admission, clinical and bacteriologic cure and mortality an d to determine the prevalence of pelvic floor dysfunction and the occurrence of Clostridium Difficile associated diarrhea;Primary end point(s): The primary outcome measure is clinical cure rate (i.e., resolution of symptoms and fever) among evaluable patients through the 10- to 18-day posttherapy visit. Evaluable patients for Intention-to-Treat analysis are those who met the following criteria: (1) enrollment criteria of febrile urinary tract infection, (2) received at least one dose of study drugs and (3) follow-up visit. Evaluable patients for Per-Protocol analysis are those who met the following criteria: (1) enrollment criteria of febrile urinary tract infection, (2) received the study drug for a minimum of 24 hours (in case of treatment failure) or received at least 80% of the study drug (in case of clinical cure) and (3) follow-up visit.

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026