Asymptomatic bacteriuria after renal transplantation.
Conditions
Interventions
Trade Name: standard of care. Patients will receive standard of care which is defined as antibiotics. The antibiotic drug will be chosen by the local study investigator according to the urine results.
Sponsors
ULB ERASME HOSPITAL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: asymptomatic bacteriuria in kidney transplant recipients after first two months post transplantation asymptomatic bacteriuria is define as isolation of a single bacterial species in a quantitative count>= 100.000 CFU/ml in a single collected urine specimen from a patient without biological or clinical signs or symptoms referable to urinary tract infection. 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 130 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
Exclusion criteria: 1. Pregnant women or women who wish to become pregnant during the course of the study 2. Presence of indwelling urinary devices such as urethral catheter, ureteral catheter, nephrostomy and/or suprapubic catheter 3. Combined transplantation (liver-kidney, lung-kidney, heart-kidney) 4. Urinary tract surgery during the last two months 5. Surgical urological procedure planned in the next two weeks 6. Neutropenia (= 2 episodes in the last year) 12. kidney transplant recipients who could not return for regular follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: the main objective of the study is to assess the incidence of a first episode of symptomatic urinary tract infection in kidney transplant recipients with asymptomatic bacteriuria.;Secondary Objective: 1. to compare the incidence of a first episode of pyelonephritis in both group. 2. to compare the proportion of patients with clearance of asymptomatic bacteriuria in both group. 3.to assess the occurence of new episodes of asymptomatic bacteriuria; 4. to assess the graft function/survival. 5. to assess the patient survival. 6. to assess the utility of a control urine culture for diagnosis of asymptomatic bacteriuria in kidney transplant recipients. 7. to assess the incidence of bacterial resistances 8. to assess the total number of days of antimicrobial therapy. 9. to assess the cost of antimicrobial treatment for asymptomatic bacteriuria and symptomatic urinary tract infection 10. to assess the number of hospitalizations for asymptomatic bacteriuria and symptomatic urinary tract infection treatment.;Primary end point(s): Symptomatic urinary tract infection. Symptomatic urinary tract infection is defined as: - Association of a positive urinalysis (>= 10.000 CFU/mL) with presence of signs or symptoms attributable to urinary tract infection. Clinical signs depend on the urinary tract infection, which can present as acute cystitis, acute pyelonephritis or acute prostatitis - (in the absence of clinical signs of urinary tract infection) positive urine culture (>= 100.000 CFU/mL) associated with fever and/or rigors and with an inflammatory syndrome unexplained by another cause (CRP level > 3 mg/dL). Pyuria is necessary for diagnosis of symptomatic urinary tract infection. ;Timepoint(s) of evaluation of this end point: M0 (baseline), M1 (one month after study inclusion), M2 (two months after study inclusion), M4, M6, M8, M10 and M12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Serum creatinine. Creatinine clearance. Graft survival. Patient survival. Asymptomatic bacteriuria clearance. Bacterial resistances. Graft rejection. Antibiotics cost. Hospitalizations cost.;Timepoint(s) of evaluation of this end point: M0 (baseline), M1 (one month after study inclusion), M2 (two months after study inclusion), M4, M6, M8, M10 and M12. | — |
Countries
Belgium
Contacts
Public ContactD.JULIEN COUSSEMENT
ULB ERASME HOSPITAL
Outcome results
None listed