Levofloxacin for Acute pyelonephritis|Kidney transplant recipient

Inclusion criteria

• {"criterion_text":"- Age >18 years Kidney Transplant Recipients\n- APN defined by: fever (T°≥38°C) (with or without clinical signs and/or symptoms of UTI) and pyuria (≥104 white blood cells/mL or ≥10/mm3) and positive urine culture (uropathogen ≥103 CFU/mL susceptible to the empirically administrated antibiotic)\n- No confirmed or suspected febrile non urinary bacterial infection\n- No urologic/renal complication at baseline imaging (abscess, obstruction...)\n- Favourable early response to antibiotic treatment:( 48 to 60 hours after the first dose of antibiotic effective against the causative uropathogen) defined by: T°<38°C and improvement (or resolution) of signs and/or symptoms of urinary tract infection if present at diagnosis.\n- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- Patients with any of the following conditions\n- First month post transplantation\n- -Current indwelling catheter (including bladder catheter, ureteral stents, percutaneous nephrostomy tubes)\n- Neurogenic bladder\n- Enterocystoplasty\n- Immunodeficiency or immunosuppressive therapy not related to kidney transplantation, including hematologic malignancy, cancer, asplenia, neutropenia<500 neutrophils/mm3,\n- Pregnancy, breastfeeding\n- Hypersensitivity or previous severe adverse drug reaction to the antibiotic therapy\n- Unable or unwilling, in the judgment of the investigator, to comply with the protocol\n- Life expectancy<1 month\n- Patient under legal guardianship or without healthcare coverage\n- Severe or complicated condition\n- Homeless patient\n- Women with childbearing potential not using adequate contraception\n- 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\n- Admission or stay in intensive care unit at baseline\n- Obstruction of the urinary tract\n- Renal, perinephric or prostatic abscess\n- prior inclusion in this study\n- current participation to another interventional study\n- Dual antibiotic therapy ((prophylactic antibiotic such as cotrimoxazole allowed) )(only 1 dose of aminoside is allowed before randomization)"}

Primary endpoints

• {"endpoint_text":"- Clinical cure 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.","definition_or_measurement_approach":"Clinical cure defined as fever <38°C and no symptoms of UTI; measured up to day 30 with requirement of no additional antibiotic treatment since end of antibiotic treatment."}

Secondary endpoints

• {"endpoint_text":"- Clinical cure at day 90 and 180","definition_or_measurement_approach":"Clinical cure assessed at days 90 and 180."}
• {"endpoint_text":"- Microbiological cure *at day 30, 90 and 180","definition_or_measurement_approach":"Microbiological cure assessed at days 30, 90 and 180."}
• {"endpoint_text":"- Incidence of relapse /recurrence between day 30 and day 90","definition_or_measurement_approach":"Measure incidence of relapse/recurrence in the interval from day 30 to day 90."}
• {"endpoint_text":"- Incidence of adverse events imputable to antibiotic treatment","definition_or_measurement_approach":"Assessment and recording of adverse events attributed to antibiotic treatment."}
• {"endpoint_text":"- Kidney function assessed according to MDRD (Modification of Diet in Renal Disease) or CKD (Chronic Kidney Disease - Epidemiology Collaboration) epi","definition_or_measurement_approach":"Kidney function measured by MDRD or CKD-EPI equations (assessments at specified time points, including day 90 and day 180)."}
• {"endpoint_text":"- Hospitalization length stay defined by the delay between the date of inclusion and the date of hospital discharge","definition_or_measurement_approach":"Length of hospital stay calculated as days between inclusion and hospital discharge."}
• {"endpoint_text":"- Antibiotic consumption","definition_or_measurement_approach":"Measurement of total antibiotic consumption during follow-up (methods not further specified)."}
• {"endpoint_text":"- Rectal carriage of antibiotic resistant Enterobacteriaceae at inclusion and day 30","definition_or_measurement_approach":"Assessment of rectal carriage of antibiotic-resistant Enterobacteriaceae at inclusion and at day 30."}

France

Earliest CTIS Part Ii Submission Date

14-05-2024

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

720

Number Of Sites

16

Number Of Participants

470

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France