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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003857-26 | EudraCT Number |
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| Name | Class |
|---|---|
| University Hospital, Lille | OTHER |
| Universitair Ziekenhuis Brussel | OTHER |
| Hôpital Necker-Enfants Malades | OTHER |
| Centre Hospitalier Universitaire Brugmann |
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The purpose of this study is to compare antibiotics versus no-treatment in kidney transplant recipients with asymptomatic bacteriuria.
The BiRT trial investigators would be interested to collaborate with some additional hospitals, particularly centers having high level of antimicrobial resistance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotics | Experimental | 10 days of antibiotics, started and selected according to the antibiogram results. In case of reinfection or relapse, re-administration of antimicrobial agents will be performed according to the antibiogram results (for a maximum of 3 cycles of ten days of antibiotics during the 12 months of the follow-up). |
|
| No treatment | No Intervention | no antibiotics delivered in case of asymptomatic bacteriuria, independently of the number of asymptomatic episodes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-Infective Agents | Other | 10 days of antibiotics, started and selected according to the antibiogram results. In case of reinfection or relapse, re-administration of antimicrobial agents will be performed according to the antibiogram results (for a maximum of 3 cycles of ten days of antibiotics during the 12 months of the follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| cumulative incidence of a first episode of symptomatic urinary tract infection | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of a first episode of pyelonephritis | 12 months | |
| clearance of asymptomatic bacteriuria | 12 months | |
| occurrence of new episodes of asymptomatic bacteriuria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julien Coussement, MD | Hôpital Universitaire Erasme, Brussels, Belgium | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Antwerpen | Antwerp | 2650 | Belgium | |||
| Centre Hospitalier Epicura |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 18, 2021 | |
| Reset | Nov 12, 2021 |
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| OTHER |
| Centre Hospitalier Universitaire de Charleroi | OTHER |
| University Ghent | OTHER |
| Centre Hospitalier Epicura, Belgium | UNKNOWN |
| University of Liege | OTHER |
| Nantes University Hospital | OTHER |
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|
|
| 12 months |
| graft function/graft survival | 12 months |
| incidence of graft rejection | 12 months |
| patient survival | 12 months |
| utility of a control urine culture for diagnosis of asymptomatic bacteriuria in kidney transplant recipients | 12 months |
| level of antimicrobial resistance in bacteria responsible for symptomatic urinary tract infections | 12 months |
| total number of days of antimicrobial therapy | 12 months |
| cost of antimicrobial treatment for asymptomatic bacteriuria and symptomatic urinary tract infection | 12 months |
| number of hospitalizations for asymptomatic bacteriuria and symptomatic urinary tract infection treatment | 12 months |
| total number of symptomatic urinary tract infections in both groups | 12 months |
| Baudour |
| 7331 |
| Belgium |
| Centre Hospitalier Universitaire Brugmann | Brussels | 1020 | Belgium |
| Hôpital Universitaire Erasme | Brussels | 1070 | Belgium |
| Universitair Ziekenhuis Brussel - Vrije Universiteit Brussel | Brussels | 1090 | Belgium |
| Centre Hospitalier Universitaire de Charleroi | Charleroi | 6110 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Centre Hospitalier Universitaire de Liège | Liège | 4000 | Belgium |
| Groupe Henri Mondor-Albert Chenevier, Assistance Publique-Hôpitaux de Paris | Créteil | 94000 | France |
| Centre Hospitalier Régional Universitaire de Lille | Lille | 59037 | France |
| Centre Hospitalier Universitaire de Nantes | Nantes | 44000 | France |
| Department of Kidney Transplantation, Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP | Paris | 75015 | France |
| Hôpital Tenon, Assistance Publique-Hôpitaux de Paris | Paris | 75020 | France |
| Centre Hospitalier Universitaire de Saint-Étienne | Saint-Etienne | 42055 | France |
| Centre Hospitalier Universitaire Rangueil | Toulouse | 31059 | France |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 18, 2021 | Nov 12, 2021 |
| ID | Term |
|---|---|
| D001437 | Bacteriuria |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital 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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