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Objective: To determine whether antibiotic treatment of asymptomatic bacteriuria in kidney transplant recipients could be useful to prevent pyelonephritis in these patients.
Design: Randomized prospective study. Setting: University Hospital with an active kidney transplantation program. Patients: Adult kidney transplant recipients. Interventions: Kidney transplant recipients with asymptomatic bacteriuria will be randomly assigned to be treated with antibiotics or to be followed without antibiotic therapy.
Measurements: Urine cultures will be collected weekly during the first month after transplantation, every 2 weeks until three months after transplantation, every month until 6 months after transplantation and every 3 months until 12 months after transplantation. Urine culture will be as well collected if urinary symptoms appeared.
Primary end points: To determine in both groups: the incidence of pyelonephritis.
Secondary end points: To determine outcomes in both groups (renal function, hospitalization, rejection, graft loss, opportunistic infections and mortality) and infection by multiresistant microorganisms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic treatment | Active Comparator | Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics. |
|
| No treatment | Other | Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic treatment | Drug | Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the incidence of pyelonephritis in both groups | First year after kidney transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function | First year after kydney transplantation | |
| Need for hospitalization | First year after kydney transplantation | |
| Incidence of graft loss |
| Measure | Description | Time Frame |
|---|---|---|
| Infection by multiresistant microorganisms | First year after kydney transplantation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Núria Sabé Fernàndez | Contact | +932607625 | nfsabe@bellvitgehospital.cat |
| Name | Affiliation | Role |
|---|---|---|
| Núria Sabé Fernàndez | Hospital Universitari de Bellvitge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vall d'Hebron | Recruiting | Barcelona | Barcelona | Spain | ||
| Hospital Universitari de Bellvitge |
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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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| No treatment | Other | Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy |
|
| First year after kidney transplantation |
| Mortality | First year after kidney transplantation |
| Recruiting |
| L'Hospitalet de Llobregat |
| Barcelona |
| 08907 |
| Spain |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011702 | Pyelitis |
| D052801 | Male Urogenital Diseases |