Comparing 7 days versus 14 days of antibiotics for kidney transplant patients with acute pyelonephritis
Efficacy of 7 Days Versus 14 Days of Antibiotic Therapy for Acute Pyelonephritis in Kidney Transplant Recipients, a Multicentre Randomized Non-inferiority Trial.
This study is testing if kidney transplant patients with a certain type of kidney infection can be treated safely with just 7 days of antibiotics instead of the usual 14 days.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 470 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 9 sites (Bordeaux and 8 other locations) |
| Trial ID | NCT05597540 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are kidney transplant recipients over 18 years old who have been diagnosed with acute pyelonephritis and have shown a favorable early response to antibiotic treatment.
Not a fit: Patients with severe or complicated conditions, such as septic shock or rapidly progressing diseases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to shorter antibiotic courses for kidney transplant recipients, reducing the risk of antibiotic resistance and improving patient outcomes.
How similar studies have performed: Other studies have explored antibiotic duration in various infections, but this specific approach in kidney transplant recipients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bordeaux and 8 other locations
- CHU Bordeaux — Bordeaux, France (Not_yet_recruiting)
- Hôpital Foch — Boulogne-Billancourt, France (Not_yet_recruiting)
- CHU Mondor — Créteil, France (Recruiting)
- CHU Lyon — Lyon, France (Not_yet_recruiting)
- CHU Nantes — Nantes, France (Recruiting)
- CHU Kremlin-Bicêtre — Paris, France (Not_yet_recruiting)
- CHU Necker — Paris, France (Recruiting)
- CHU Saint Louis — Paris, France (Recruiting)
- CHU Toulouse — Toulouse, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Matthieu Lafaurie, MD
- Email: matthieu.lafaurie@aphp.fr
- Phone: 142494117
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.