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Efficacy of 7 days versus 14 days of antibiotic therapy for acute pyelonephritis in kidney transplant recipients
EU CTIS ID: 2024-513328-40-00
What this study is testing
To show that a 7 day-antibiotic therapy is not inferior to a 14 day-antibiotic therapy in the treatment of acute pyelonephritis in kidney transplant recipients.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age >18 years Kidney Transplant Recipients
- APN defined by: fever (T°≥38°C) (with or without clinical signs and/or symptoms of UTI) and pyuria (≥104 white blood cells/mL or ≥10/mm3) and positive urine culture (uropathogen ≥103 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
You likely can't join if
- Patients with any of the following conditions
- 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,
See the full eligibility criteria
- Age >18 years Kidney Transplant Recipients
- APN defined by: fever (T°≥38°C) (with or without clinical signs and/or symptoms of UTI) and pyuria (≥104 white blood cells/mL or ≥10/mm3) and positive urine culture (uropathogen ≥103 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
- Patients with any of the following conditions
- 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
- Severe or complicated condition
- Homeless patient
- Women with childbearing potential not using adequate contraception
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.