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SHORTCUT - Efficacy of 7 days versus 14 days of antibiotic therapy for acute pyelonephritis in kidney transplant recipients, a multicenter randomized non-inferiority trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513328-40-00
Acronym
APHP200020
Enrollment
470
Registered
2024-06-19
Start date
2024-03-25
Completion date
Unknown
Last updated
2024-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pyelonephritis, Kidney Transplant recipients

Brief summary

Clinical cure and no additional antibiotic treatment since the end of antibiotic treatment up to the main evaluation at day 30. Clinical cure is defined as fever <38°C and no symptoms of UTI.

Detailed description

Clinical cure at day 90 and 180, Microbiological cure *at day 30, 90 and 180, Incidence of relapse /recurrence between day 30 and day 90, Incidence of adverse events imputable to antibiotic treatment, Kidney function assessed according to MDRD (Modification of Diet in Renal Disease) or CKD (Chronic Kidney Disease - Epidemiology Collaboration) epi, Hospitalization length stay defined by the delay between the date of inclusion and the date of hospital discharge, Antibiotic consumption, Rectal carriage of antibiotic resistant Enterobacteriaceae at inclusion and day 30

Interventions

Sponsors

Assistance Publique Hopitaux De Paris, Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Clinical cure and no additional antibiotic treatment since the end of antibiotic treatment up to the main evaluation at day 30. Clinical cure is defined as fever <38°C and no symptoms of UTI.

Secondary

MeasureTime frame
Clinical cure at day 90 and 180, Microbiological cure *at day 30, 90 and 180, Incidence of relapse /recurrence between day 30 and day 90, Incidence of adverse events imputable to antibiotic treatment, Kidney function assessed according to MDRD (Modification of Diet in Renal Disease) or CKD (Chronic Kidney Disease - Epidemiology Collaboration) epi, Hospitalization length stay defined by the delay between the date of inclusion and the date of hospital discharge, Antibiotic consumption, Rectal carriage of antibiotic resistant Enterobacteriaceae at inclusion and day 30

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026