Febrile Urinary Tract Infection Randomized Short Treatment Trial

Urinary Tract Infection Clinical Trial

— FUTIRST  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809913
• Other study ID #: NL22172.058.08
• Status: Completed
• Phase: Phase 4
• First received: December 16, 2008
• Last updated: September 15, 2016
• Start date: December 2008
• Est. completion date: September 2013

Study information

• Verified date: September 2016
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Fever
• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• short treatment (ciprofloxacin)
7 days of antibiotic treatment for febrile urinary tract infection / acute pyelonephritis compared to standard treatment of 14 days

Locations

Country	Name	City	State
Netherlands	Bronovo Hospital	Den Haag
Netherlands	Medical Center Haaglanden	Den Haag
Netherlands	Groene Hart Hospital	Gouda
Netherlands	Alrijne Hospital	Leiden
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Alrijne Hospital	Leiderdorp

Sponsors (7)

Lead Sponsor	Collaborator
Leiden University Medical Center	Bronovo Hospital, Diaconessenhuis Leiden, Groene Hart Ziekenhuis, Medical Center Haaglanden, Rijnland Hospital, Spaarne Ziekenhuis

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Microbiological cure rate 10- to 18-day posttherapy		10-18 day posttherapy	No
Secondary	All cause mortality		30 and 90 days	No
Secondary	Clinical cure rate 70- to 84- day posttherapy		70-84 days posttherapy	No
Secondary	Relapse rate of any urinary tract infection		90 days	No
Secondary	Adverse events		90 days	Yes
Secondary	Rate of pelvic floor dysfunction as assessed by standardized questionaire		10-18 days posttherapy	No
Secondary	Occurence of Clostridium Difficile associated diarrhea		90 days	No