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

Mahidol University

Status and phase: Completed; Phase 2

Conditions: Asymptomatic Infections; Kidney Transplantation; Bacteriuria

Treatments: Drug: 14 days course of antibiotic treatment; Drug: 7 days course of antibiotic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02575495

EC_580278

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

7 days course of antibiotic treatment

Experimental group

Description:

To assign the 7 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture

Treatment:

Drug: 7 days course of antibiotic treatment

14 days course of antibiotic treatment

Active Comparator group

Description:

To assign the 14 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture

Treatment:

Drug: 14 days course of antibiotic treatment