Efficacy of 7 Days Versus 14 Days of Antibiotic Therapy for Acute Pyelonephritis in Kidney Transplant Recipients, a Multicentre Randomized Non-inferiority Trial.

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Oct 24, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating whether a 7-day course of antibiotics is as effective as a 14-day course for treating acute pyelonephritis, a type of kidney infection, in people who have received a kidney transplant. Researchers want to find out if shorter antibiotic treatment can help patients recover just as well while also reducing the risk of developing antibiotic-resistant infections, which are a growing concern in transplant patients.

To participate in the trial, individuals must be over 18 years old and have a confirmed case of acute pyelonephritis, which is indicated by fever and certain lab results. They should show an early positive response to antibiotic treatment within 48 hours. However, there are several conditions that would exclude someone from joining, such as severe illness, certain complications, or being in the first month after a kidney transplant. Those who enroll can expect close monitoring and care, with the aim of improving their health and contributing to better treatment options for future kidney transplant recipients.

Gender

ALL

Eligibility 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 or ≥10/mm3) and positive urine culture (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...)
• • 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:
• • Severe or complicated condition
• • 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)
• • 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
• • Homeless patient
• • Women with childbearing potential not using adequate contraception