Clinical trial NCT02575495: A Randomized Control Trial of Antibiotic Treatment Duration For Asymptomatic Bacteriuria After Kidney Transplantation
Official title: A Pilot Randomized Control Study of Shortening Antibiotic Treatment Duration For Asymptomatic Bacteriuria Within A Month After Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Transplantation
Bacteriuria
Asymptomatic Infections
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate
timeFrame: 1 month
Secondary outcomes:
measure: Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate
timeFrame: 0.5 months
measure: Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and
timeFrame: 3 months
measure: duration of hospital stay
timeFrame: 30 days since randomization
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Pattraporn Ponglorpisit
state: Bangkok
Study officials:
affiliation: Faculty of Medicine Ramathibodi Hospital, Mahidol University
name: Pattraporn Ponglorpisit, MD
role: PRINCIPAL_INVESTIGATOR
References: