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Study identifier: NCT05597540 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Pyelonephritis Acute · Kidney Transplant Infection  ·  Sponsor: Assistance Publique - Hôpitaux de Paris

PhasePhase 3
Planned participants470
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Infections are a major cause of morbidity and mortality in solid organ transplant recipients. In kidney transplant recipients (KTR) urinary tract infection (UTI) represent 45-72% of all infections, and 30% of all hospitalizations for sepsis. Acute transplant pyelonephritis are the most common complications occurring in more than 20% of patients, mainly in the first year after transplantation. They are associated with an increased risk of acute kidney rejection and long-term kidney graft dysfunction. Gram-negative bacteria, mainly E. coli, account for more than 70% of UTI in KTR. As those infections are favoured by urinary tract modifications/defects and immunosuppression, they are often recurrent and necessitate repeated courses of antibiotics. Selective pressure due to antibiotic consumption, along with frequent hospital admissions and immunosuppression, are well known risk factors for the development of antibiotic resistant infections. Multidrug (MDR)- or extensively (XDR)- drug resistant Enterobacteriaceae including ESBL- or carbapenemase-producing organisms, are thus increasingly observed in transplant units and represent a global threat as very few new antibiotics are expected in the next decade. One main strategy to limit antimicrobial resistance is to reduce the duration of antibiotic treatment. A 7 day-course is recommended for simple acute pyelonephritis (APN) treated with fluoroquinolones or parenteral B-lactams, prolonged up to 10 or 14 days in the presence of und…

This description comes directly from the study's public registry record.

Talk to the study team

Matthieu Lafaurie, MD  ·  142494117  ·  matthieu.lafaurie@aphp.fr

Jérôme Lambert, Pr  ·  142499742  ·  jerome.lambert@u-paris.fr

Always discuss trial participation with your own doctor first.

Locations (9)

CHU BordeauxBordeaux, FranceNot Yet Recruiting
Hôpital FochBoulogne-Billancourt, FranceNot Yet Recruiting
CHU MondorCréteil, FranceRecruiting
CHU LyonLyon, FranceNot Yet Recruiting
CHU NantesNantes, FranceRecruiting
CHU Kremlin-BicêtreParis, FranceNot Yet Recruiting
CHU NeckerParis, FranceRecruiting
CHU Saint LouisParis, FranceRecruiting
CHU ToulouseToulouse, FranceNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT05597540