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Febrile Urinary Tract Infection Randomized Short Treatment Trial (FUTIRST)

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ClinicalTrials.gov Identifier: NCT00809913
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : September 16, 2016
Sponsor:
Collaborators:
Bronovo Hospital
Medical Center Haaglanden
Spaarne Gasthuis
Rijnland Hospital
Diaconessenhuis Leiden
Groene Hart Ziekenhuis
Information provided by (Responsible Party):
C. van Nieuwkoop, Leiden University Medical Center

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Drug: short treatment (ciprofloxacin) Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2008
Actual Primary Completion Date : May 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Short treatment
7 days of standard antibiotic treatment (preferably ciprofloxacin) followed by 7 days of placebo
Drug: short treatment (ciprofloxacin)
7 days of antibiotic treatment for febrile urinary tract infection / acute pyelonephritis compared to standard treatment of 14 days

Active Comparator: Standard treatment
14 days of standard antibiotic treatment (initial b-lactam or fluoroquinolone followed by ciprofloxacin through the 8th till 14th day)
Drug: short treatment (ciprofloxacin)
7 days of antibiotic treatment for febrile urinary tract infection / acute pyelonephritis compared to standard treatment of 14 days




Primary Outcome Measures :
  1. 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. [ Time Frame: 10-18 day posttherapy ]

Secondary Outcome Measures :
  1. Microbiological cure rate 10- to 18-day posttherapy [ Time Frame: 10-18 day posttherapy ]
  2. All cause mortality [ Time Frame: 30 and 90 days ]
  3. Clinical cure rate 70- to 84- day posttherapy [ Time Frame: 70-84 days posttherapy ]
  4. Relapse rate of any urinary tract infection [ Time Frame: 90 days ]
  5. Adverse events [ Time Frame: 90 days ]
  6. Rate of pelvic floor dysfunction as assessed by standardized questionaire [ Time Frame: 10-18 days posttherapy ]
  7. Occurence of Clostridium Difficile associated diarrhea [ Time Frame: 90 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809913


Locations
Netherlands
Medical Center Haaglanden
Den Haag, Netherlands, 2501 CK
Bronovo Hospital
Den Haag, Netherlands, 2509 JH
Groene Hart Hospital
Gouda, Netherlands, 2800 BB
Leiden University Medical Center
Leiden, Netherlands, 2300 RC
Alrijne Hospital
Leiden, Netherlands, 2334 CK
Alrijne Hospital
Leiderdorp, Netherlands, 2350 CC
Sponsors and Collaborators
Leiden University Medical Center
Bronovo Hospital
Medical Center Haaglanden
Spaarne Gasthuis
Rijnland Hospital
Diaconessenhuis Leiden
Groene Hart Ziekenhuis
Investigators
Study Chair: Jaap T. van Dissel, MD, PhD Leiden University Medical Center
Principal Investigator: Cees van Nieuwkoop, MD, PhD Leiden University Medical Center and Haga Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: C. van Nieuwkoop, MD, PhD, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT00809913     History of Changes
Other Study ID Numbers: NL22172.058.08
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016

Keywords provided by C. van Nieuwkoop, Leiden University Medical Center:
Urinary Tract Infection
Fever
Acute Pyelonephritis
Treatment duration
Febrile Urinary Tract Infection Treatment Duration

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Ciprofloxacin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors