Febrile Urinary Tract Infection Randomized Short Treatment Trial

Condition(s) targeted: Urinary Tract Infection

Intervention: short treatment (ciprofloxacin) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Leiden University Medical Center

Official(s) and/or principal investigator(s):
Jaap T. van Dissel, MD, PhD, Study Chair, Affiliation: Leiden University Medical Center
Cees van Nieuwkoop, MD, Principal Investigator, Affiliation: Leiden University Medical Center

Overall contact:
Cees van Nieuwkoop, MD, Phone: +31-71-5262613, Email: c.van _nieuwkoop@lumc.nl

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.

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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome:

Microbiological cure rate 10- to 18-day posttherapy

All cause mortality

Clinical cure rate 70- to 84- day posttherapy

Relapse rate of any urinary tract infection

Adverse events

Rate of pelvic floor dysfunction as assessed by standardized questionaire

Occurence of Clostridium Difficile associated diarrhea

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Cees van Nieuwkoop, MD, Phone: +31-71-5262613, Email: c.van _nieuwkoop@lumc.nl

Leiden University Medical Center, Leiden 2300 RC, Netherlands; Recruiting
Cees van Nieuwkoop, MD, Phone: +31-71-5262613, Email: c.van_nieuwkoop@lumc.nl
Jaap T. van Dissel, MD,PhD, Phone: +31-71-5262613, Email: j.t.van_dissel@lumc.nl
Cees van Nieuwkoop, MD, Principal Investigator

Ziekenhuis Bronovo, Den Haag 2509 JH, Netherlands; Not yet recruiting
Jan van't Wout, MD, PhD, Phone: +31-70-3124141, Email: jvtwout@bronovo.nl
Jan van't Wout, MD, PhD, Sub-Investigator

Medisch Centrum Haaglanden, Den Haag 2501 CK, Netherlands; Not yet recruiting
Eliane M.S. Leyten, MD, PhD, Phone: +70-31-3302000, Email: e.leyten@mchaaglanden.nl
Eliane M.S. Leyten, MD, PhD, Sub-Investigator

Spaarne Ziekenhuis, Hoofddorp 2134 TM, Netherlands; Not yet recruiting
G. Hanke Wattel - Louis, MD, Phone: +31-23-8907171, Email: hwattel@spaarneziekenhuis.nl
G. Hanke Wattel - Louis, MD, Sub-Investigator

Rijnland Ziekenhuis, Leiderdorp 2350 CC, Netherlands; Not yet recruiting
Natahalie M. Delfos, MD, Phone: +31-71-5828282, Email: n.delfos@rijnland.nl
Nathalie M. Delfos, MD, Sub-Investigator

Diaconessenhuis Leiden, Leiden 2334 CK, Netherlands; Not yet recruiting
Hans C. Ablij, MD, Phone: +31-71-5178178, Email: hcablij@diaconessenhuis.nl
Hans C. Ablij, MD, Sub-Investigator

Groene Hart Ziekenhuis, Gouda 2800 BB, Netherlands; Not yet recruiting
Ted Koster, MD, PhD, Phone: +31-182-505050, Email: ted.koster@ghz.nl
Ted Koster, MD, PhD, Sub-Investigator

Starting date: December 2008
Ending date: December 2010
Last updated: December 17, 2008