Febrile Urinary Tract Infection Randomized Short Treatment Trial.

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).

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20802

Enrollment

400

Registered

2008-12-19

Start date

2008-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

urinary tarct infection, acute pyelonephritis, urosepsis

Interventions

7 days of standard antiobiotic treatment (preferably ciprofloxacin) followed by 7 days of blinded oral ciprofloxacin (500 mg bid) or placebo (bid).

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

Measure	Time frame
The 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

Measure	Time frame
This 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.	—

Contacts

Public ContactDept. of Infectious Diseases, C5P C. van Nieuwkoop

PO Box 9600

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)