NCT00809913

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2008

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

4.4 years

First QC Date

December 16, 2008

Last Update Submit

September 15, 2016

Conditions

Urinary Tract Infection

Keywords

Urinary Tract InfectionFeverAcute PyelonephritisTreatment durationFebrile Urinary Tract Infection Treatment Duration

Outcome Measures

Primary Outcomes (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.

    10-18 day posttherapy

Secondary Outcomes (7)

  • Microbiological cure rate 10- to 18-day posttherapy

    10-18 day posttherapy

  • All cause mortality

    30 and 90 days

  • Clinical cure rate 70- to 84- day posttherapy

    70-84 days posttherapy

  • Relapse rate of any urinary tract infection

    90 days

  • Adverse events

    90 days

  • +2 more secondary outcomes

Study Arms (2)

Short treatment

EXPERIMENTAL

7 days of standard antibiotic treatment (preferably ciprofloxacin) followed by 7 days of placebo

Drug: short treatment (ciprofloxacin)

Standard treatment

ACTIVE COMPARATOR

14 days of standard antibiotic treatment (initial b-lactam or fluoroquinolone followed by ciprofloxacin through the 8th till 14th day)

Drug: short treatment (ciprofloxacin)

Interventions

short treatment (ciprofloxacin)DRUG

7 days of antibiotic treatment for febrile urinary tract infection / acute pyelonephritis compared to standard treatment of 14 days

Short treatmentStandard treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Groene Hart Hospital

Gouda, 2800 BB, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Alrijne Hospital

Leiden, 2334 CK, Netherlands

Location

Alrijne Hospital

Leiderdorp, 2350 CC, Netherlands

Location

Medical Center Haaglanden

The Hague, 2501 CK, Netherlands

Location

Bronovo Hospital

The Hague, 2509 JH, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 19691829BACKGROUND

  • 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.

    PMID: 30764769DERIVED

  • 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.

    PMID: 28366170DERIVED

MeSH Terms

Conditions

Urinary Tract InfectionsFever

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jaap T. van Dissel, MD, PhD

    Leiden University Medical Center

    STUDY CHAIR

  • Cees van Nieuwkoop, MD, PhD

    Leiden University Medical Center and Haga Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 16, 2008

First Posted

December 17, 2008

Study Start

December 1, 2008

Primary Completion

May 1, 2013

Study Completion

September 1, 2013

Last Updated

September 16, 2016

Record last verified: 2016-09

Locations

NL(6)