A Phase 2 interventional study of 7 days course of antibiotic treatment and 14 days course of antibiotic treatment in Kidney Transplantation, Bacteriuria and Asymptomatic Infections, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2016-03-16.
Sponsored by Mahidol University · Phase 2, Interventional, and Treatment
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.
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.
51 studies on the registry are indexed under Bacteriuria; 3 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 37 interventional studies indexed under Bacteriuria.
Browse Bacteriuria studies →Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.
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Exclusion Criteria:
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
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 7 days
Also known as: short-course antibiotic treatment
start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 14 days
Also known as: traditional-course antibiotic treatment
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate
Composite end point at 1 month after discontinuing antibiotics
Time frame: 1 month
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate
Composite end point at 0.5 months after discontinuing antibiotics
Time frame: 0.5 months
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and
Composite end point at 3 months after discontinuing antibiotics
Time frame: 3 months
duration of hospital stay
duration of hospital stay
Time frame: 30 days since randomization
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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