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Trial record 24 of 759 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

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

Tracking Information
First Submitted Date  ICMJE October 8, 2015
First Posted Date  ICMJE October 14, 2015
Last Update Posted Date March 16, 2016
Study Start Date  ICMJE February 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02575495 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2015)
  • 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
  • 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
  • duration of hospital stay [ Time Frame: 30 days since randomization ]
    duration of hospital stay
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Control Trial of Antibiotic Treatment Duration For Asymptomatic Bacteriuria After Kidney Transplantation
Official Title  ICMJE A Pilot Randomized Control Study of Shortening Antibiotic Treatment Duration For Asymptomatic Bacteriuria Within A Month After Kidney Transplantation
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Kidney Transplantation
  • Bacteriuria
  • Asymptomatic Infections
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: 7 days course of 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
    Intervention: Drug: 14 days course of antibiotic treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2016)
20
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2015)
60
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02575495
Other Study ID Numbers  ICMJE EC_580278
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pattraporn Ponglorpisit, MD Faculty of Medicine Ramathibodi Hospital, Mahidol university
PRS Account Mahidol University
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP