Efficacy of 7 days versus 14 days of antibiotic therapy for acute pyelonephritis in kidney transplant recipients

Phase 1

Recruiting

• Conditions: Pyelonephritis, Kidney Transplant recipients; Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]; Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2024-513328-40-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-31
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

Age >18 years Kidney Transplant Recipients, 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), No confirmed or suspected febrile non urinary bacterial infection, No urologic/renal complication at baseline imaging (abscess, obstruction...), 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., Written informed consent

Exclusion Criteria

Patients with any of the following conditions, 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 neutrophils/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, Severe or complicated condition, Homeless patient, Women with childbearing potential not using adequate contraception, 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 antibiotic therapy ((prophylactic antibiotic such as cotrimoxazole allowed) )(only 1 dose of aminoside is allowed before randomization)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified