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Clinical Trials in the EU / 2025-523120-53-00
Completed Phase III

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

2025-523120-53-00 · tracked via the Priya Life Science EU tracker
Sponsor
Bellvitge University Hospital, Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL
Sponsor type
Hospital/Clinic/Other health care facility, Laboratory/Research/Testing facility
Therapeutic area
Bacterial Infections and Mycoses
Decision date
02/03/2026
Enrollment target
360
Sites
Spain

Condition studied

Graft pyelonephritis in kidney transplant recipients

Investigational medicinal product(s)

CIPROFLOXACINCIPROFLOXACINCEFTRIAXONECEFTRIAXONE

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

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.

Endpoint detail

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.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523120-53-00 on CTIS ↗ ← All trials in the EU