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Prospective Multicenter Randomized Non-Inferiority Study Comparing 7 Days Versus 14 Days of Antibiotic Treatment for Graft Pyelonephritis in Kidney Transplant Recipients (KTI)

Status
Not yet recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523120-53-00
Enrollment
360
Registered
2026-03-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Graft pyelonephritis in kidney transplant recipients

Brief summary

Definida a los 90 días de la inclusión por: Mortalidad por cualquier causa, o recurrencia de la pielonefritis del injerto, o reingreso por cualquier causa después del alta hospitalaria por el episodio de pielonefritis.

Detailed description

Total days of antibiotics since diagnosis of graft pyelonephritis., Total days of intravenous antibiotics since diagnosis of graft pyelonephritis., Total days of admission since diagnosis of graft pyelonephritis., Number of adverse events and interactions with concomitant treatments during hospitalization and at 90 days after the patient's inclusion in the study., Episodes of catheter-related adverse events during admission and at 90 days after the patient's inclusion in the study., Episodes of Clostridioides difficile at 90 days after the patient's inclusion in the study., Evolution of renal function at 90 days from the patient's inclusion in the study., Episodes of rejection and graft loss within 90 days of the patient's inclusion in the study., Isolated microorganisms and antibiotic sensitivity in control urine cultures at 30 and 90 days after the patient's inclusion in the study.

Interventions

DRUGCIPROFLOXACIN
DRUGCEFTRIAXONE

Sponsors

Bellvitge University Hospital, Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Definida a los 90 días de la inclusión por: Mortalidad por cualquier causa, o recurrencia de la pielonefritis del injerto, o reingreso por cualquier causa después del alta hospitalaria por el episodio de pielonefritis.

Secondary

MeasureTime frame
Total days of antibiotics since diagnosis of graft pyelonephritis., Total days of intravenous antibiotics since diagnosis of graft pyelonephritis., Total days of admission since diagnosis of graft pyelonephritis., Number of adverse events and interactions with concomitant treatments during hospitalization and at 90 days after the patient's inclusion in the study., Episodes of catheter-related adverse events during admission and at 90 days after the patient's inclusion in the study., Episodes of Clostridioides difficile at 90 days after the patient's inclusion in the study., Evolution of renal function at 90 days from the patient's inclusion in the study., Episodes of rejection and graft loss within 90 days of the patient's inclusion in the study., Isolated microorganisms and antibiotic sensitivity in control urine cultures at 30 and 90 days after the patient's inclusion in the study.

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 3, 2026