Asymptomatic Infections, Bacteriuria, Kidney Transplantation
Conditions
Brief summary
The major hypothesis to be tested is that there was no difference in the clinical outcome between 7(short-course) and 14(traditional-course) days of antibiotic treatment for asymptomatic bacteriuria early after kidney transplantation.
Detailed description
Introduction: Treatment of asymptomatic bacteriuria is a common practice in renal transplant centers leading to prolong exposure of antimicrobial agents with long hospital length of stay. The duration of antibiotics treatment in this condition have never been proposed. Objective: To evaluate the proper duration of antibiotic treatment for asymptomatic bacteriuria early (less than 1 month) after kidney transplantation Method: This is a prospective, randomized, open labeled, single center study using intention to treat analysis. Patients will be identified and after informed consent is obtained, will be randomized to receive 7 or 14 days course of antibiotics.
Interventions
start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 7 days
start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 14 days
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* First kidney transplantation * Asymptomatic bacteriuria
Exclusion criteria
* Refusal to participate in the study * Re-transplantation or combined organ transplantation * History of abnormal structure or function in native kidney, ureter and bladder system * Kidney transplant recipients with history of recurrent urinary tract infection or incomplete course of urinary tract infection treatment before transplantation * Hemodynamic unstable * Urosepsis or other serious infectious complications(eg. symptomatic urinary tract infection/graft pyelonephritis, surgical site infection, infected urinoma/ hospital acquired pneumonia that mandates antibiotic therapy) * Surgical complication (eg. anastomosis leakage, collection, ureteric stricture)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate | 1 month | Composite end point at 1 month after discontinuing antibiotics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate | 0.5 months | Composite end point at 0.5 months after discontinuing antibiotics |
| Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and | 3 months | Composite end point at 3 months after discontinuing antibiotics |
| duration of hospital stay | 30 days since randomization | duration of hospital stay |
Countries
Thailand
Outcome results
None listed