Informations générales (source: ClinicalTrials.gov)
Efficacy of 7 Days Versus 14 Days of Antibiotic Therapy for Acute Pyelonephritis in Kidney Transplant Recipients, a Multicentre Randomized Non-inferiority Trial.
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
février 2024
août 2027
13 septembre 2025
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 underlying disease at risk of complications. Most KT teams treat patients
between 14-21 days as recommended by American guidelines. However, the need to extend
treatment duration in immunosuppressed patients is a poorly defined concept and the
optimal duration of treatment for APN in KTR is not known as these patients are excluded
from most studies.
As there is an urgent need to reduce antibiotic consumption in this population at high
risk of developing infections due to resistant pathogens, the hypothesis is that a 7
day-treatment is sufficient to cure APN with good clinical response after 48h of
treatment in KTR and is as effective as 14 days.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Arwa Jalal eddine | 15/12/2025 08:26:42 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:25:55 | Contacter | |||
| AP-HP - Hôpital Bicêtre | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| AP-HP - Hôpital Necker-Enfants Malades | |||||
| AP-HP - Hôpital Saint Louis | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Bordeaux - Bordeaux - France | Hannah Kaminski, Dr | Contact (sur clinicalTrials) | |||
| CHU Lyon - Lyon - France | Charlene Levi, Dr | Contact (sur clinicalTrials) | |||
| CHU Mondor - Créteil - France | Marie Matignon, Dr | Contact (sur clinicalTrials) | |||
| CHU Nantes - Nantes - France | Clément Deltombe, Dr | Contact (sur clinicalTrials) | |||
| CHU Saint Louis - Paris - France | Gillian Divard, Dr | Contact (sur clinicalTrials) | |||
| CHU Toulouse - Toulouse - France | Nassim Kamar, Pr | Contact (sur clinicalTrials) | |||
| Hôpital Foch - Boulogne-Billancourt - France | Michel Delahousse, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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