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Compares treatment options for Pyelonephritis Acute
Official title Efficacy of 7 Days Versus 14 Days of Antibiotic Therapy for Acute Pyelonephritis in Kidney Transplant Recipients, a Multicentre Randomized Non-inferiority Trial.
ClinicalTrials.gov ID: NCT05597540
What this study is testing
What is Short antibiotic treatment?
Short antibiotic treatment is an investigational medicine, being studied as a potential treatment for pyelonephritis acute.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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)...
You likely can't join if
- Severe or complicated condition
- Any rapidly progressing disease or immediately life-threatening illness, including, but not limited to, septic shock, current or impeding respiratory...
- Admission or stay in intensive care unit at baseline
- Obstruction of the urinary tract
- Renal, perinephric or prostatic abscess
- Prior inclusion in this study
See the full eligibility 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...
- 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...
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Boulogne-Billancourt, France
- Créteil, France
- Lyon, France
- Nantes, France
- Paris, France
- Toulouse, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Boulogne-Billancourt, France; Créteil, France; Lyon, France; Nantes, France; Paris, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.