Urinary Tract InfectionPhase 4FUTIRSTNCT00809913
Febrile Urinary Tract Infection Randomized Short Treatment Trial
A Phase 4 study testing short treatment (ciprofloxacin) in people with Urinary Tract Infection, run by Leiden University Medical Center at 6 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- short treatment (ciprofloxacin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesNetherlands
- Study dates
- Dec 2008to Sep 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Groene Hart Hospital
Gouda, 2800 BB
Leiden University Medical Center
Leiden, 2300 RC
Alrijne Hospital
Leiden, 2334 CK
Alrijne Hospital
Leiderdorp, 2350 CC
Medical Center Haaglanden
The Hague, 2501 CK
Bronovo Hospital
The Hague, 2509 JH
About this study
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)
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.
Read the 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.
- Conditions
- Urinary Tract Infection
- Being tested
- short treatment (ciprofloxacin)
- Keywords
- Urinary Tract Infection, Fever, Acute Pyelonephritis, Treatment duration, Febrile Urinary Tract Infection Treatment Duration
- Medical subject headings
- Urinary Tract Infections, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short treatment (ciprofloxacin)Drug
7 days of antibiotic treatment for febrile urinary tract infection / acute pyelonephritis compared to standard treatment of 14 days
| Study group | Role | What they receive |
|---|---|---|
| Short treatment | Experimental | 7 days of standard antibiotic treatment (preferably ciprofloxacin) followed by 7 days of placebo Receives: 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) Receives: Drug: short treatment (ciprofloxacin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10-18 day posttherapy
Secondary outcomes (7)
Microbiological cure rate 10- to 18-day posttherapy
Measured: 10-18 day posttherapy
All cause mortality
Measured: 30 and 90 days
Clinical cure rate 70- to 84- day posttherapy
Measured: 70-84 days posttherapy
Relapse rate of any urinary tract infection
Measured: 90 days
Adverse events
Measured: 90 days
Rate of pelvic floor dysfunction as assessed by standardized questionaire
Measured: 10-18 days posttherapy
Occurence of Clostridium Difficile associated diarrhea
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionMay 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bronovo Hospital, Medical Center Haaglanden, Spaarne Gasthuis, Rijnland Hospital, Diaconessenhuis Leiden, Groene Hart Ziekenhuis
- Responsible party
- Principal investigator, C. van Nieuwkoop, Leiden University Medical Center
- Investigators
- Jaap T. van Dissel, MD, PhD, Study chair, Leiden University Medical CenterCees van Nieuwkoop, MD, PhD, Principal investigator, Leiden University Medical Center and Haga Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809913
- Sponsor's protocol ID
- NL22172.058.08
- Acronym
- FUTIRST
- Status last verified
- Sep 2016
- First submitted
- 16 Dec 2008
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19691829Stalenhoef 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.
PubMed 30764769van 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.
PubMed 28366170
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00809913
- Acronym / sponsor ID
- FUTIRST / NL22172.058.08
- Conditions
- Urinary Tract Infection
- Keywords
- Urinary Tract Infection, Fever, Acute Pyelonephritis, Treatment duration, Febrile Urinary Tract Infection Treatment Duration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Bronovo Hospital, Medical Center Haaglanden, Spaarne Gasthuis, Rijnland Hospital, Diaconessenhuis Leiden, Groene Hart Ziekenhuis
- Study start
- Dec 2008
- Primary completion
- May 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short treatment | Experimental | Drug: short treatment (ciprofloxacin)7 days of standard antibiotic treatment (preferably ciprofloxacin) followed by 7 days of placebo |
| Standard treatment | Active comparator | Drug: short treatment (ciprofloxacin)14 days of standard antibiotic treatment (initial b-lactam or fluoroquinolone followed by ciprofloxacin through the 8th till 14th day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| short treatment (ciprofloxacin)7 days of antibiotic treatment for febrile urinary tract infection / acute pyelonephritis compared to standard treatment of 14 days | Drug | Short treatment, Standard treatment |
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.
Time frame: 10-18 day posttherapy
7 secondary outcomes
Microbiological cure rate 10- to 18-day posttherapy
Time frame: 10-18 day posttherapy
All cause mortality
Time frame: 30 and 90 days
Clinical cure rate 70- to 84- day posttherapy
Time frame: 70-84 days posttherapy
Relapse rate of any urinary tract infection
Time frame: 90 days
Adverse events
Time frame: 90 days
Rate of pelvic floor dysfunction as assessed by standardized questionaire
Time frame: 10-18 days posttherapy
Occurence of Clostridium Difficile associated diarrhea
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
- Background: PubMed 19691829van 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.
- Derived from this study: PubMed 30764769Stalenhoef 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.
- Derived from this study: PubMed 28366170van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaap T. van Dissel, MD, PhD study chair
Leiden University Medical Center
Cees van Nieuwkoop, MD, PhD principal investigator
Leiden University Medical Center and Haga Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing short treatment (ciprofloxacin) in people with Urinary Tract Infection, run by Leiden University Medical Center at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00809913, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016.