Febrile Urinary Tract Infection Randomized Short Treatment Trial

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
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)

Conditions
-----------------
Urinary Tract Infection

Intervention / Treatment
-----------------
* Drug: short treatment (ciprofloxacin)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short treatment<br>7 days of standard antibiotic treatment (preferably ciprofloxacin) followed by 7 days of placebo | Drug: short treatment (ciprofloxacin)<br>* 7 days of antibiotic treatment for febrile urinary tract infection / acute pyelonephritis compared to standard treatment of 14 days<br>|
| Active Comparator: Standard treatment<br>14 days of standard antibiotic treatment (initial b-lactam or fluoroquinolone followed by ciprofloxacin through the 8th till 14th day) | Drug: short treatment (ciprofloxacin)<br>* 7 days of antibiotic treatment for febrile urinary tract infection / acute pyelonephritis compared to standard treatment of 14 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure rate through the 10- to 18-day posttherapy visit. Clinical cure is defined as the resolution of fever and signs and symptoms of UTI. |  | 10-18 day posttherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological cure rate 10- to 18-day posttherapy |  | 10-18 day posttherapy | 
| All cause mortality |  | 30 and 90 days | 
| Clinical cure rate 70- to 84- day posttherapy |  | 70-84 days posttherapy | 
| Relapse rate of any urinary tract infection |  | 90 days | 
| Adverse events |  | 90 days | 
| Rate of pelvic floor dysfunction as assessed by standardized questionaire |  | 10-18 days posttherapy | 
| Occurence of Clostridium Difficile associated diarrhea |  | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary Tract Infection, Fever, Acute Pyelonephritis, Treatment duration, Febrile Urinary Tract Infection Treatment Duration