Back to resultsA Randomized Control Trial of Antibiotic Treatment Duration For Asymptomatic Bacteriuria After Kidney Transplantation
Primary Purpose
Kidney Transplantation, Bacteriuria, Asymptomatic Infections
Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
7 days course of antibiotic treatment
14 days course of antibiotic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Transplantation
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)
Sites / Locations
- Pattraporn Ponglorpisit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
7 days course of antibiotic treatment
14 days course of antibiotic treatment
Arm Description
To assign the 7 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture
To assign the 14 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture
Outcomes
Primary Outcome Measures
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate
Composite end point at 1 month after discontinuing antibiotics
Secondary Outcome Measures
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate
Composite end point at 0.5 months after discontinuing antibiotics
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and
Composite end point at 3 months after discontinuing antibiotics
duration of hospital stay
duration of hospital stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02575495
Brief Title
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
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation, Bacteriuria, Asymptomatic Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
7 days course of antibiotic treatment
Arm Type
Experimental
Arm Description
To assign the 7 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture
Arm Title
14 days course of antibiotic treatment
Arm Type
Active Comparator
Arm Description
To assign the 14 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture
Intervention Type
Drug
Intervention Name(s)
7 days course of antibiotic treatment
Other Intervention Name(s)
short-course antibiotic treatment
Intervention Description
start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 7 days
Intervention Type
Drug
Intervention Name(s)
14 days course of antibiotic treatment
Other Intervention Name(s)
traditional-course antibiotic treatment
Intervention Description
start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 14 days
Primary Outcome Measure Information:
Title
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate
Description
Composite end point at 1 month after discontinuing antibiotics
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate
Description
Composite end point at 0.5 months after discontinuing antibiotics
Time Frame
0.5 months
Title
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and
Description
Composite end point at 3 months after discontinuing antibiotics
Time Frame
3 months
Title
duration of hospital stay
Description
duration of hospital stay
Time Frame
30 days since randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pattraporn Ponglorpisit, MD
Organizational Affiliation
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pattraporn Ponglorpisit
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
A Randomized Control Trial of Antibiotic Treatment Duration For Asymptomatic Bacteriuria After Kidney Transplantation
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