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

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ClinicalTrials.gov Identifier: NCT02575495
Recruitment Status : Completed
First Posted : October 14, 2015
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Mahidol University

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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Bacteriuria Asymptomatic Infections Drug: 7 days course of antibiotic treatment Drug: 14 days course of antibiotic treatment Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Randomized Control Study of Shortening Antibiotic Treatment Duration For Asymptomatic Bacteriuria Within A Month After Kidney Transplantation
Study Start Date : February 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: 7 days course of antibiotic treatment
start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 7 days
Other Name: short-course antibiotic treatment

Active Comparator: 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
Drug: 14 days course of antibiotic treatment
start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 14 days
Other Name: traditional-course antibiotic treatment




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575495


Locations
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Thailand
Pattraporn Ponglorpisit
Ratchathewi, Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Pattraporn Ponglorpisit, MD Faculty of Medicine Ramathibodi Hospital, Mahidol university

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02575495     History of Changes
Other Study ID Numbers: EC_580278
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents
Antitubercular Agents
Bacteriuria
Asymptomatic Infections
Urinary Tract Infections
Infection
Urologic Diseases
Asymptomatic Diseases
Disease Attributes
Pathologic Processes
Antibiotics, Antitubercular