Kidney Transplant recipient with acute pyelonephritis
Conditions
Interventions
Product Name: beta-lactamine
Pharmaceutical Form:
Product Name: Fluoroquinolones
Pharmaceutical Form:
Trade Name: cotrimoxazole
Product Name: cotrimoxazole
Pharmaceutical Form:
Product Name: Ami
Sponsors
Assistance Publique - Hôpitaux de Paris
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age >18 years KTR -APN defined by: fever (T°=38°C) (with or without clinical signs and/or symptoms of UTI) and pyuria (=10.4 white blood cells/mL) and positive urine culture (single uropathogen =10.3 CFU/mL susceptible to the empirically administrated antibiotic) -No confirmed or suspected febrile non urinary bacterial infection -No urologic/renal complication at baseline imaging (abscess, obstruction...) - Early response after 48h of antibiotic treatment defined by: T°=65 years) yes F.1.3.1 Number of subjects for this age range 470
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions: -Severe or complicated - Any rapidly progressing disease or immediately life-threatening illness, including, but not limited to, septic shock, current or impeding respiratory failure, acute heart or liver failure - Admission or stay in intensive care unit at baseline - Obstruction of the urinary tract - Renal, perinephric or prostatic abscess - prior inclusion in this study - current participation to another interventional study -Dual therapy (only 1 dose of aminoside is allowed before randomization) -First month post transplantation -Current indwelling catheter (including bladder catheter, ureteral stents, percutaneous nephrostomy tubes) -Neurogenic bladder -Enterocystoplasty -Immunodeficiency or immunosuppressive therapy not related to kidney transplantation, including hematologic malignancy, cancer, asplenia, neutropenia<500 PNN/mm3, -Pregnancy, breastfeeding -Hypersensitivity or previous severe adverse drug reaction to the antibiotic therapy -Unable or unwilling, in the judgment of the investigator, to comply with the protocol -Life expectancy<1 month -Patient under legal guardianship or without healthcare coverage -Homeless patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show that a 7 day-antibiotic therapy is not inferior to a 14 day-antibiotic therapy in the treatment of acute pyelonephritis in kidney transplant recipients.;Secondary Objective: o compare between both arms: -Clinical and microbiological efficacy at day 90 and day 180 -Tolerance and safety of antibiotics -Hospitalisation length stay -Antibiotic consumption during total follow up -Acquisition of antibiotic resistant Enterobacteriaceae -Kidney graft function and transplant rejection at day 90 and day 180 - The total costs. To evaluate risk factors for failure and relapse. ;Primary end point(s): Clinical cure and microbiological eradication and no additional antibiotic treatment since the end of antibiotic treatment up to the main evaluation at day 30. Clinical cure is defined as fever <38°C and no symptoms of UTI. Microbiological eradication is defined as uropathogen = 10.3 CFU/mL in urine culture ;Timepoint(s) of evaluation of this end point: Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical cure and microbiological eradication at day 90 and 180 - Incidence of relapse /recurrence between day 30 and day 90 - Incidence of adverse events imputable to antibiotic treatment - MDRD (Modification of Diet in Renal Disease) and CKD (Chronic Kidney Disease - Epidemiology Collaboration) epi at day 90 and day 180 - Hospitalisation length stay defined by the delay between the date of inclusion and the date of hospital discharge - Antibiotic consumption - Rectal carriage of antibiotic resistant Enterobacteriaceae at day 30 ;Timepoint(s) of evaluation of this end point: Day 180 | — |
Countries
France
Contacts
Public ContactDRCI
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed