Febrile Urinary Tract Infection Randomized Short Treatment Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urinary Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Short treatment

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

Group Type EXPERIMENTAL

short treatment (ciprofloxacin)

Intervention Type DRUG

7 days of antibiotic treatment for febrile urinary tract infection / acute pyelonephritis compared to standard treatment of 14 days

Standard treatment

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

Group Type ACTIVE_COMPARATOR

short treatment (ciprofloxacin)

Intervention Type DRUG

7 days of antibiotic treatment for febrile urinary tract infection / acute pyelonephritis compared to standard treatment of 14 days

Interventions

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short treatment (ciprofloxacin)

7 days of antibiotic treatment for febrile urinary tract infection / acute pyelonephritis compared to standard treatment of 14 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No