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Febrile Urinary Tract Infection Randomized Short Treatment Trial.

- candidate number4799
- NTR NumberNTR1583
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-dec-2008
- Secondary IDsNCT00809913
- Public TitleFebrile Urinary Tract Infection Randomized Short Treatment Trial.
- Scientific TitleRelevance 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).
- hypothesisA 7-day course of antibiotic treatment is non-inferior to a 14-day course in febrile urinary tract infection.
- Healt Condition(s) or Problem(s) studiedUrinary tract infections, Urosepsis, Acute pyelonefritis
- Inclusion criteria1. Competent patient aged 18 years or above;
2. One or more symptom(s) suggestive of urinary tract infection (dysuria, frequency or urgency*; perineal or suprapubic pain; costo-vertebral tenderness or flank pain);
3. 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;
4. Positive urine nitrate test and/or leucocyturia as depicted by positive leukocyte esterase test or microscopy.
- Exclusion criteria1. Known allergy to fluoroquinolones;
2. Female patients who are pregnant or lactating;
3. Patients with known polycystic kidney disease;
4. Patients on permanent renal replacement therapy (hemodialysis or peritoneal dialysis);
5. Patients with history of kidney transplantation;
6. Residence outside country of enrolment;
7. Inability to speak or read Dutch;
8. Isolation of causal ciprofloxacin resistant uropahtogen;
9. Presence of renal abcess, chronic bacterial prostatitis or metastatic infectiuous foci.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2008
- planned closingdate30-sep-2010
- Target number of participants400
- Interventions7 days of standard antiobiotic treatment (preferably ciprofloxacin) followed by 7 days of blinded oral ciprofloxacin (500 mg bid) or placebo (bid).
- Primary outcomeThe 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.
- Secondary outcomeThis includes microbiological cure rate 10- to 18-day posttherapy, 30- and 90- day overall mortality rate, clinical cure rate 70- to 84- day posttherapy, time to resolution of symptoms, relapse rate of UTI, adverse events or complications, rate of pelvic floor dysfunction as assessed by a standardize questionaire and the occurrence of Clostridium difficile disease.
- TimepointsDay 0, 3-4, 24-32 and 84-98.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESLeiden University Medical Center Dept. of Infectious Diseases, C5P C. van Nieuwkoop
- CONTACT for SCIENTIFIC QUERIESProf. dr. J.T. Dissel, van
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- Publications
- Brief summaryIn the last decades hospitalization rates of patients with acute pyelonephritis (AP) or febrile urinary tract infection (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. Again, based 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 and 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.
- Main changes (audit trail)
- RECORD19-dec-2008 - 21-jan-2009

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