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

NCT ID: NCT02575495

Last Updated: 2016-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-02-29

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.

Conditions

Kidney Transplantation; Bacteriuria; Asymptomatic Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

7 days course of antibiotic treatment

Intervention Type: DRUG

start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 7 days

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

Group Type: ACTIVE_COMPARATOR

14 days course of antibiotic treatment

Intervention Type: DRUG

start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 14 days

Interventions

7 days course of antibiotic treatment

start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 7 days

Intervention Type: DRUG

14 days course of antibiotic treatment

start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 14 days

Intervention Type: DRUG

Other Intervention Names

short-course antibiotic treatment; traditional-course antibiotic treatment

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)

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pattraporn Ponglorpisit, MD

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital

Locations

Pattraporn Ponglorpisit

Ratchathewi, Bangkok, Thailand

Countries

Thailand

Other Identifiers

EC_580278

Identifier Type: -

Identifier Source: org_study_id