Ignite Creation Date:
2024-05-06 @ 6:14 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05597540
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2022-10-24
Brief Title:
Efficacy of 7 Days Versus 14 Days of Antibiotic Therapy for Acute Pyelonephritis in Kidney Transplant Recipients a Multicentre Randomized Non-inferiority Trial
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHORTCUT
Brief Summary:
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 modificationsdefects 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None