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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Antibiotic adjusted to antibiogram | Experimental | 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 |
|
| B: no treatment | No Intervention | No treatment of any episode of asymptomatic bacteriuria beyond 2 months after transplantation in kidney transplant recipients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic adjusted to antibiogram | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years after transplantation |
| Incidence of Clostridium difficile infection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco López-Medrano, MD,PhD | López-Medrano, Francisco, M.D. | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27088545 | Derived | Origuen J, Lopez-Medrano F, Fernandez-Ruiz M, Polanco N, Gutierrez E, Gonzalez E, Merida E, Ruiz-Merlo T, Morales-Cartagena A, Perez-Jacoiste Asin MA, Garcia-Reyne A, San Juan R, Orellana MA, Andres A, Aguado JM. Should Asymptomatic Bacteriuria Be Systematically Treated in Kidney Transplant Recipients? Results From a Randomized Controlled Trial. Am J Transplant. 2016 Oct;16(10):2943-2953. doi: 10.1111/ajt.13829. Epub 2016 May 23. |
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| ID | Term |
|---|---|
| D011704 | Pyelonephritis |
| ID | Term |
|---|---|
| D009395 | Nephritis, Interstitial |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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|
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. |
| 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. | 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. | At 1 year and 2 years after transplantation |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011702 | Pyelitis |
| D052801 | Male Urogenital Diseases |