Febrile Urinary Tract Infection Randomized Short Treatment Trial (FUTIRST)

Leiden University Medical Center (LUMC)

Status and phase: Completed; Phase 4

Conditions: Urinary Tract Infection

Treatments: Drug: short treatment (ciprofloxacin)

Study type: Interventional

Funder types: Other

Identifiers

NCT00809913

NL22172.058.08

Details and patient eligibility

About

The purpose of this study is to determine whether a 7-day duration of antibiotic treatment of febrile urinary tract infection (FUTI) is non inferior to 14-day standard duration of treatment in unselected population presenting at primary care or emergency department.

Full description

In the last decades hospitalization rates of patients with acute pyelonephritis (AP) or FUTI has decreased from almost 100% to 10-30%. The outpatient management of patients with FUTI has become popular as well as oral antimicrobial treatment regiments and shortening of treatment duration. However, as such approaches are only discovered in otherwise young health non-pregnant women, the best management of FUTI in the elderly, men and patients with co-morbidity remains elusive. Bases on personal perception of the attending physician antibiotic treatment, duration varies approximately between 7-14 days. Facing the aging of the general population, it is urgent to better define the optimal treatment for AP or FUTI in an unselected population and to identify those at risk for treatment failure or poor outcome to guide and optimize individual patient management and to prevent on the one hand unnecessary long treatment duration and hospital admission and on the other hand unsafe short duration or unsafe outpatient management.

In this study the efficacy and safety of a 7-day antimicrobial regimen compared to a 14-day antimicrobial regimen will be evaluated in an unselected population presenting with FUTI at primary care or emergency department. In addition a clinical and/or biomarker based scoring system of disease severity will be derived to predict those at risk for treatment failure or poor outcome.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Competent patient aged 18 years or above
• One or more symptom(s) suggestive of urinary tract infection (dysuria, frequency or urgency*; perineal or suprapubic pain; costo-vertebral tenderness or flank pain)
• 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
• Positive urine nitrate test and/or leucocyturia as depicted by positive leukocyte esterase test or microscopy

Exclusion criteria

• Known allergy to fluoroquinolones
• Female patients who are pregnant or lactating
• Patients with known polycystic kidney disease
• Patients on permanent renal replacement therapy (hemodialysis or peritoneal dialysis)
• Patients with history of kidney transplantation
• Residence outside country of enrolment
• Inability to speak or read Dutch
• Isolated causal uropathogen resistant to ciprofloxacin
• Renal abscess
• Chronic bacterial prostatitis
• Suspicion or evidence of any metastatic infectious foci

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Short treatment

Experimental group

Description:

7 days of standard antibiotic treatment (preferably ciprofloxacin) followed by 7 days of placebo

Treatment:

Drug: short treatment (ciprofloxacin)

Standard treatment

Active Comparator group

Description:

14 days of standard antibiotic treatment (initial b-lactam or fluoroquinolone followed by ciprofloxacin through the 8th till 14th day)

Treatment:

Drug: short treatment (ciprofloxacin)