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Febrile Urinary Tract Infection Randomized Short Treatment Trial (FUTIRST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Leiden University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Bronovo Hospital
Medical Center Haaglanden
Spaarne Ziekenhuis
Rijnland Hospital
Diaconessenhuis Leiden
Groene Hart Ziekenhuis
Information provided by (Responsible Party):
C. van Nieuwkoop, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT00809913
First received: December 16, 2008
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Urinary Tract Infection
Drug: short treatment (ciprofloxacin)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Microbiological cure rate 10- to 18-day posttherapy [ Time Frame: 10-18 day posttherapy ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: 30 and 90 days ] [ Designated as safety issue: No ]
  • Clinical cure rate 70- to 84- day posttherapy [ Time Frame: 70-84 days posttherapy ] [ Designated as safety issue: No ]
  • Relapse rate of any urinary tract infection [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Rate of pelvic floor dysfunction as assessed by standardized questionaire [ Time Frame: 10-18 days posttherapy ] [ Designated as safety issue: No ]
  • Occurence of Clostridium Difficile associated diarrhea [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: December 2008
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809913

Contacts
Contact: Cees van Nieuwkoop, MD, PhD +31-71-5262613 c.vannieuwkoop@hagaziekenhuis.nl
Contact: Jaap T. van Dissel, MD, PhD +31-71-5262613 j.t.van_dissel@lumc.nl

Locations
Netherlands
Bronovo Hospital Recruiting
Den Haag, Netherlands, 2509 JH
Contact: Jan van't Wout, MD, PhD    +31-70-3124141    jvtwout@bronovo.nl   
Sub-Investigator: Jan van't Wout, MD, PhD         
Medical Center Haaglanden Recruiting
Den Haag, Netherlands, 2501 CK
Contact: Eliane M.S. Leyten, MD, PhD    +70-31-3302000    e.leyten@mchaaglanden.nl   
Sub-Investigator: Eliane M.S. Leyten, MD, PhD         
Groene Hart Hospital Recruiting
Gouda, Netherlands, 2800 BB
Contact: Ted Koster, MD, PhD    +31-182-505050    ted.koster@ghz.nl   
Sub-Investigator: Ted Koster, MD, PhD         
Spaarne Hospital Not yet recruiting
Hoofddorp, Netherlands, 2134 TM
Contact: G. Hanke Wattel - Louis, MD    +31-23-8907171    hwattel@spaarneziekenhuis.nl   
Sub-Investigator: G. Hanke Wattel - Louis, MD         
Diaconessenhuis Leiden Recruiting
Leiden, Netherlands, 2334 CK
Contact: Hans C. Ablij, MD    +31-71-5178178    hcablij@diaconessenhuis.nl   
Sub-Investigator: Hans C. Ablij, MD         
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2300 RC
Contact: Cees van Nieuwkoop, MD    +31-71-5262613    c.van_nieuwkoop@lumc.nl   
Contact: Jaap T. van Dissel, MD,PhD    +31-71-5262613    j.t.van_dissel@lumc.nl   
Principal Investigator: Cees van Nieuwkoop, MD         
Rijnland Hospital Recruiting
Leiderdorp, Netherlands, 2350 CC
Contact: Natahalie M. Delfos, MD    +31-71-5828282    n.delfos@rijnland.nl   
Sub-Investigator: Nathalie M. Delfos, MD         
Sponsors and Collaborators
Leiden University Medical Center
Bronovo Hospital
Medical Center Haaglanden
Spaarne Ziekenhuis
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
  More Information

Publications:
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
Study First Received: December 16, 2008
Last Updated: March 19, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Leiden University Medical Center:
Urinary Tract Infection
Fever
Acute Pyelonephritis
Treatment duration
Febrile Urinary Tract Infection Treatment Duration

Additional relevant MeSH terms:
Urinary Tract Infections
Communicable Diseases
Infection
Urologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Ciprofloxacin
Anti-Infective Agents
Antineoplastic Agents
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014