Kidney Transplantation Clinical Trial
Official title:
A Pilot Randomized Control Study of Shortening Antibiotic Treatment Duration For Asymptomatic Bacteriuria Within A Month After Kidney Transplantation
Verified date | March 2016 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ethical Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | February 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years and older |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Pattraporn Ponglorpisit | Ratchathewi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate | Composite end point at 1 month after discontinuing antibiotics | 1 month | Yes |
Secondary | Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate | Composite end point at 0.5 months after discontinuing antibiotics | 0.5 months | Yes |
Secondary | Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and | Composite end point at 3 months after discontinuing antibiotics | 3 months | Yes |
Secondary | duration of hospital stay | duration of hospital stay | 30 days since randomization | No |
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