Comparing 7 days versus 14 days of antibiotics for kidney transplant patients with acute pyelonephritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy of a shorter 7-day antibiotic treatment compared to the standard 14-day regimen for kidney transplant recipients suffering from acute pyelonephritis. The study focuses on patients who have shown a favorable early response to antibiotic therapy, assessing whether a reduced duration of treatment can effectively manage their infections without compromising patient safety. By conducting this multicenter randomized non-inferiority trial, researchers hope to address the issue of antibiotic resistance and improve treatment protocols for urinary tract infections in this vulnerable population.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Mondor
  Créteil, France Recruiting
• CHU Nantes
  Nantes, France Recruiting
• CHU Necker
  Paris, France Recruiting
• CHU Saint Louis
  Paris, France Recruiting
• CHU Bordeaux
  Bordeaux, France Not yet recruiting
• Hôpital Foch
  Boulogne-Billancourt, France Not yet recruiting

Study contacts

• Study coordinator: Matthieu Lafaurie, MD
• Email: matthieu.lafaurie@aphp.fr
• Phone: 142494117

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.