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van CCT (UK)

van CCT (UK)

Prediction Rule for Admission policy in Complicated urinary Tract InfeCtion LEiden.

- candidate number17011
- NTR NumberNTR4480
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-mrt-2014
- Secondary IDsNL35220.058.11 ZonMW 171101003
- Public TitlePrediction Rule for Admission policy in Complicated urinary Tract InfeCtion LEiden.
- Scientific TitleImplementation of a clinical decision rule to optimize hospital admission policy of patients with febrile urinary tract infection.
- hypothesisIntroduction of the PRACTICE into clinical practice leads to lower hospitalization rates without compromising clinical outcome, and lower medical costs.
- Healt Condition(s) or Problem(s) studiedUrinary tract infections, Urosepsis, Acute pyelonefritis, Acute prostatitis
- 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 C or higher, or axillary temp of 38 C 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;
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2012
- planned closingdate1-jun-2015
- Target number of participants652
- InterventionsUse of the PRACTICE to guide physicians, summing the points for each characteristic: age in years (females age-10); nursing home resident +10; malignancy +30; liver cirrhosis +20; congestive heart failure +10; cerebrovascular disease +10; renal disease +10; altered mental status +20; respiratory rate °› 30/min +20; systolic blood pressure <90 mmHg +20; pulse rate >124/min +10; temperature >39.9 C +15. Recommendations: <75 points: strongly recommendation towards home-based management; 75-100 points: consider home-based management; >100 points: strongly recommendation towards hospital admission.
- Primary outcome- Primary hospital admission rate.
- Secondary hospital admission rate defined as the percentage of patients who need to be hospitalized after initially being treated at home.
- Secondary outcome- Total number of hospitalization days over a 3-month follow-up
- 30-day and 90-day mortality rate
- Intensive Care Unit admission rate
- Hospitalization costs during 3-month follow-up
- Patientsí satisfaction with application of the PRACTICE
- Clinical- and microbiological cure rate
- TimepointsDay 0, 2-4, 24-32 and 84-98.
- Trial web site
- statusstopped: trial finished
- CONTACT for SCIENTIFIC QUERIESProf. dr. J.T. Dissel, van
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summary
- Main changes (audit trail)5-mei-2014:
- Group: stepped wedge clusterdesign
- Control: standard care - AB
- RECORD25-mrt-2014 - 17-okt-2015

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