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| Name | Class |
|---|---|
| Bronovo Hospital | OTHER |
| Medical Center Haaglanden | OTHER |
| Spaarne Gasthuis | OTHER |
| Rijnland Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short treatment | Experimental | 7 days of standard antibiotic treatment (preferably ciprofloxacin) followed by 7 days of placebo |
|
| Standard treatment | Active Comparator | 14 days of standard antibiotic treatment (initial b-lactam or fluoroquinolone followed by ciprofloxacin through the 8th till 14th day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| short treatment (ciprofloxacin) | Drug | 7 days of antibiotic treatment for febrile urinary tract infection / acute pyelonephritis compared to standard treatment of 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groene Hart Hospital | Gouda | 2800 BB | Netherlands | |||
| Leiden University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19691829 | Background | 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. | |
| 30764769 |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D005334 | Fever |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| OTHER |
| Diaconessenhuis Leiden | UNKNOWN |
| Groene Hart Ziekenhuis | OTHER |
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| 70-84 days posttherapy |
| Relapse rate of any urinary tract infection | 90 days |
| Adverse events | 90 days |
| Rate of pelvic floor dysfunction as assessed by standardized questionaire | 10-18 days posttherapy |
| Occurence of Clostridium Difficile associated diarrhea | 90 days |
| Leiden |
| 2300 RC |
| Netherlands |
| Alrijne Hospital | Leiden | 2334 CK | Netherlands |
| Alrijne Hospital | Leiderdorp | 2350 CC | Netherlands |
| Medical Center Haaglanden | The Hague | 2501 CK | Netherlands |
| Bronovo Hospital | The Hague | 2509 JH | Netherlands |
| Derived |
| 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. |
| 28366170 | Derived | 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |