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NCT Number: NCT02575495

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

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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Key information

Conditions

Kidney Transplantation Asymptomatic Diseases Asymptomatic Infections Bacteriuria Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pattraporn Ponglorpisit

Ratchathewi, Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

7 days course of antibiotic treatment

Drug

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

Other names: short-course antibiotic treatment

14 days course of antibiotic treatment

Drug

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

Other names: traditional-course antibiotic treatment

Primary outcomes

  1. Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate

    Time frame: 1 month

    Composite end point at 1 month after discontinuing antibiotics

Secondary outcomes

  1. Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate

    Time frame: 0.5 months

    Composite end point at 0.5 months after discontinuing antibiotics

  2. Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and

    Time frame: 3 months

    Composite end point at 3 months after discontinuing antibiotics

  3. duration of hospital stay

    Time frame: 30 days since randomization

    duration of hospital stay

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 14, 2015
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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