Clinical trial NCT00809913: Febrile Urinary Tract Infection Randomized Short Treatment Trial
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Tract Infection
Keywords: Urinary Tract Infection
Fever
Acute Pyelonephritis
Treatment duration
Febrile Urinary Tract Infection Treatment Duration
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Bronovo Hospital
name: Medical Center Haaglanden
name: Spaarne Gasthuis
name: Rijnland Hospital
name: Diaconessenhuis Leiden
name: Groene Hart Ziekenhuis
First posted: 2008-12-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 10-18 day posttherapy
Secondary outcomes:
measure: Microbiological cure rate 10- to 18-day posttherapy
timeFrame: 10-18 day posttherapy
measure: All cause mortality
timeFrame: 30 and 90 days
measure: Clinical cure rate 70- to 84- day posttherapy
timeFrame: 70-84 days posttherapy
measure: Relapse rate of any urinary tract infection
timeFrame: 90 days
measure: Adverse events
timeFrame: 90 days
measure: Rate of pelvic floor dysfunction as assessed by standardized questionaire
timeFrame: 10-18 days posttherapy
measure: Occurence of Clostridium Difficile associated diarrhea
timeFrame: 90 days
Other outcomes:
Locations:
city: Den Haag
country: Netherlands
facility: Medical Center Haaglanden
city: Den Haag
country: Netherlands
facility: Bronovo Hospital
city: Gouda
country: Netherlands
facility: Groene Hart Hospital
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Leiden
country: Netherlands
facility: Alrijne Hospital
city: Leiderdorp
country: Netherlands
facility: Alrijne Hospital
Study officials:
affiliation: Leiden University Medical Center
name: Jaap T. van Dissel, MD, PhD
role: STUDY_CHAIR
affiliation: Leiden University Medical Center and Haga Hospital
name: Cees van Nieuwkoop, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Nieuwkoop C, van't Wout JW, Assendelft WJ, Elzevier HW, Leyten EM, Koster T, Wattel-Louis GH, Delfos NM, Ablij HC, Kuijper EJ, Pander J, Blom JW, Spelt IC, van Dissel JT. Treatment duration of febrile urinary tract infection (FUTIRST trial): a randomized placebo-controlled multicenter trial comparing short (7 days) antibiotic treatment with conventional treatment (14 days). BMC Infect Dis. 2009 Aug 19;9:131. doi: 10.1186/1471-2334-9-131.
citation: Stalenhoef JE, van Nieuwkoop C, Wilson DC, van der Starre WE, van der Reijden TJK, Delfos NM, Leyten EMS, Koster T, Ablij HC, van 't Wout JJW, van Dissel JT. Procalcitonin, mid-regional proadrenomedullin and C-reactive protein in predicting treatment outcome in community-acquired febrile urinary tract infection. BMC Infect Dis. 2019 Feb 14;19(1):161. doi: 10.1186/s12879-019-3789-6.
citation: van Nieuwkoop C, van der Starre WE, Stalenhoef JE, van Aartrijk AM, van der Reijden TJ, Vollaard AM, Delfos NM, van 't Wout JW, Blom JW, Spelt IC, Leyten EM, Koster T, Ablij HC, van der Beek MT, Knol MJ, van Dissel JT. Treatment duration of febrile urinary tract infection: a pragmatic randomized, double-blind, placebo-controlled non-inferiority trial in men and women. BMC Med. 2017 Apr 3;15(1):70. doi: 10.1186/s12916-017-0835-3.