A Randomized Control Trial of Antibiotic Treatment Duration For Asymptomatic Bacteriuria After Kidney Transplantation

NCT02575495 — Phase 2, Completed, 20 participants, Mahidol University

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A Pilot Randomized Control Study of Shortening Antibiotic Treatment Duration For Asymptomatic Bacteriuria Within A Month After Kidney Transplantation

Registry	NCT02575495
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	20 (Actual)
Sponsor	Mahidol University (Other)
Conditions	Kidney Transplantation, Bacteriuria, Asymptomatic Infections
Interventions	7 days course of antibiotic treatment, 14 days course of antibiotic treatment (Drug)
Dates	start 2015-02-01, primary completion 2016-01-01, completion 2016-02-01, first posted 2015-10-14, last updated 2016-03-16
Locations	1 site in Thailand

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
7 days course of antibiotic treatment	Experimental	Drug: 7 days course of antibiotic treatment	To assign the 7 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture
14 days course of antibiotic treatment	Active comparator	Drug: 14 days course of antibiotic treatment	To assign the 14 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture

7 days course of antibiotic treatment (Drug), also known as short-course antibiotic treatment: start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 7 days
14 days course of antibiotic treatment (Drug), also known as traditional-course antibiotic treatment: start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 14 days

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 15 Years to any

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)

+Locations (1)

Facility	City	Country	Status
Pattraporn Ponglorpisit	Ratchathewi, Bangkok	Thailand

+Investigators

Pattraporn Ponglorpisit, MD, Principal investigator, Ramathibodi Hospital