Prospective Comparative Study About Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A: Antibiotic adjusted to antibiogram 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
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.
Other Names:
|
| No Intervention: B: no treatment No treatment of any episode of asymptomatic bacteriuria beyond 2 months after transplantation in kidney transplant recipients. |
Outcome Measures
Primary Outcome Measures
- Incidence of Pyelonephritis [2 years after transplantation]
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.
Secondary Outcome Measures
- Incidence of lower tract urinary infection [2 years after transplantation]
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.
- Incidence of Clostridium difficile infection [2 years after transplantation]
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.
- Incidence of multidrug resistant bacteria colonization/infection [2 years after transplantation]
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.
- Long-term graft function [At 1 year and 2 years after transplantation]
Long-term graft function measured by average serum creatinine at several points until the end of follow-up.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Adult patients developing asymptomatic bacteriuria beyond 2 months after transplantation.
Exclusion Criteria:
-
<18 years old
-
Pregnant women
-
Kidney-pancreas transplantation
-
Double J stent catheterization at the momento of randomization
-
Permanent vesical catheter
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- López-Medrano, Francisco, M.D.
Investigators
- Principal Investigator: Francisco López-Medrano, MD,PhD, López-Medrano, Francisco, M.D.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ABTxR-H12O