An interventional study of Antibiotic adjusted to antibiogram in Asymptomatic Bacteriuria, sponsored by López-Medrano, Francisco, M.D.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-26.
Sponsored by López-Medrano, Francisco, M.D. · Not applicable, Interventional, and Prevention
Antimicrobial treatment of asymptomatic bacteriuria (AB) in kidney transplant recipients (KTR) is controversial. The investigators performed a comparative, parallel-group, randomized, open-label study to assess, in a real clinical setting, the feasibility of and benefit derived from systematic search and antimicrobial treatment of all episodes of AB.
All patients undergoing KT between January 2011 and December 2013 in a tertiary-care center with an active transplantation program were systematically searched for AB within the first 2 years after transplantation on a regular basis. During the first 2 months after transplantation all episodes of AB were treated. Thereafter, patients were assigned, according to a computer-generated randomization sequence, to group A (systematic antimicrobial treatment of all episodes of AB) or group B (no treatment). Treatment was chosen according to the results of the urine culture.
79 studies on the registry are indexed under Pyelonephritis; 12 are open to participants now.
This study's enrollment of 112 is below the median of 175 across 62 interventional studies indexed under Pyelonephritis.
Browse Pyelonephritis studies →This is the only study on the registry with López-Medrano, Francisco, M.D. as lead sponsor.
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Exclusion Criteria:
A course of 3-14 days of antimicrobial treatment, according to the antibiogram results, will be prescribed for every episode of asymptomatic bacteriuria beyond 2 months after transplantation and during the first 2 years after transplantation
Other: Antibiotic adjusted to antibiogram
No treatment of any episode of asymptomatic bacteriuria beyond 2 months after transplantation in kidney transplant recipients.
A course of 3-14 days of antimicrobial treatment, according to the antibiogram results, will be prescribed for every episode of asymptomatic bacteriuria during the first 2 years after transplantation.
Also known as: Anti-infective agents
Incidence of Pyelonephritis
The number of patients that develope pyelonephritis in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
Time frame: 2 years after transplantation
Incidence of lower tract urinary infection
The number of patients that develope lower tract urinary infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
Time frame: 2 years after transplantation
Incidence of Clostridium difficile infection
The number of patients that develope Clostridium difficile infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
Time frame: 2 years after transplantation
Incidence of multidrug resistant bacteria colonization/infection
The number of patients that develope multidrug resistant bacteria colonization/infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
Time frame: 2 years after transplantation
Long-term graft function
Long-term graft function measured by average serum creatinine at several points until the end of follow-up.
Time frame: At 1 year and 2 years after transplantation
No study locations are listed for this record.
The record gives a start of Jan 2011, a primary completion of Aug 2014 and a completion of Jan 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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