Shorter treatment of catheter related urinary tract infections

INTERVENTION: Trade Name: Rocephin Pharmaceutical Form: Trade Name: Gentamicine Pharmaceutical Form: Trade Name: Amoxicillin/Clavulanic Acid Pharmaceutical Form: Trade Name: Cefotaxim Pharmaceutical Form: Trade Name: Cefuroxim Pharmaceutical Form: Trade Name: Ceftazidim Pharmaceutical Form: Trade Name: Ciprofloxacin PCH Pharmaceutical Form: Trade Name: Amoxicilline/Clavulanic Acid Pharmaceutical Form: Trade Name: Co‐trimoxazol Pharmaceutical Form: Trade Name: Meronem Pharmaceutical Form: Trade Name: Amoxicillin Pharmaceutical Form: Trade Name: Tobramycin Pharmaceutical Form: Trade Name: Amoxicllin Pharmaceutical Form: Trade Name: Vancomycine Pharmaceutical Form: CONDITION: Catheter related urinary tract infection (CAUTI) Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main Objective: The primary objective of this study is to establish non‐inferiority of treating a symptomatic urinary tract infection in patients with a long‐term indwelling catheter for 5 days, compared to the standard duration of 10 days of therapy. Primary end point(s): The primary study endpoint is the recurrence of a symptomatic UTI Secondary Objective: Secondary objectives are to establish differences between the two treatment durations in:; ‐ resistance pattern of cultured microorganisms, up to 90 days after randomization; ‐ total antibiotic consumption, overall and for UTI, during 90 days after randomization; ‐ incidence of acute hospitalizations for urinary tract infection, during 90 days after randomization ; ‐ incidence of C. difficile associated diarrhea, during 90 days after randomization ; Timepoint(s) of evaluation of this end point: 90 days after randomization SECONDARY OUTCOME: Secondary end point(s): Secondary study endpoints are: ; 1. recurrence of a symptomatic UTI during 180 days after randomization. ; 2. time to recurrence of symptomatic UTI ; 3. clinical and microbiological cure at end‐of‐treatment ; 4. results of urine cultures at day 30 and day 90 after randomization ; 5. resistance pattern of cultured microorganisms after end‐of‐treatment ; 6. total antibiotic consumption, overall and for UTI during 90 days after randomization ; 7. acute hospitalizations for UTI during 90 days after randomization ; 8. C. difficile associated diarrhea during 90 days after randomization Timepoint(s) of evaluation of this end point: 1. 180 days after randomization ; 2. 180 days after randomization ; 3. Intervention group: day 5 after randomization, control group: day 10 after randomization. ; 4. Day 30 and day 90 after randomization. ; 5. Intervention group: day 5 after randomization, control group: day 10 after randomization. ; 6. 90 days after randomization ; 7. 90 days after randomization ; 8. 90 days after randomization INCLUSION CRITERIA: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Indwelling (transurethral or supra‐pubic) urinary catheter with the intention for long‐term continuous catheterization, at least for the next 28 days 2. Signs/symptoms of a systemic UTI, following the modified Loeb criteria [23,24]: a. patient feels sick 3. Positive dipstick leucocyte esterase test, or sediment > 10 leucocytes/mm3 b. at least one of the following signs: Fever > 37.9 ºC; Rigors; New onset delirium; New/worsened costovertebral angle tenderness or other local signs of UTI; In patients with spinal cord injury: increase of spasticity [27] Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150