ciprofloxacin hydrochloride, ciprofloxacin for Graft pyelonephritis

Inclusion criteria

• {"criterion_text":"- Adult kidney transplant recipients ≥ 18 years of age, of both sexes, who experience an episode of acute graft pyelonephritis at any time from the transplant to 48 hours after the start of antibiotic treatment."}
• {"criterion_text":"- Patients must be willing and able to provide written informed consent for the trial. If a subject is unable to provide written informed consent independently, a legal representative may do so in their place."}

Exclusion criteria

• {"criterion_text":"- Clinical instability 48 hours after the start of antibiotic treatment due to an episode of acute graft pyelonephritis defined as: hypotension, anuria, fever equal to or greater than 38ºC, need for vasopressor drugs or admission to the intensive care unit."}
• {"criterion_text":"- Pregnant or breastfeeding patients."}
• {"criterion_text":"- Patients with known anatomical alterations that predispose to urinary tract infections (such as vesicoureteral reflux or obstructive prostatic hypertrophy)."}
• {"criterion_text":"- Presence of urinary catheters such as bladder catheters or ureteral catheters."}
• {"criterion_text":"- Presence of complications such as urinary obstruction or kidney abscess."}
• {"criterion_text":"- Kidney transplant recipients admitted for an episode of graft pyelonephritis in the previous 30 days."}
• {"criterion_text":"- Participation in another clinical trial in which the protocol establishes antibiotic treatment for pyelonephritis."}
• {"criterion_text":"- Previous inclusion in the present study."}
• {"criterion_text":"- No authorization from the patient or their legal representative to sign the informed consent."}
• {"criterion_text":"- Any medical, psychiatric, or family condition that, in the investigator's judgment, could jeopardize or compromise the patient's ability to participate in the study."}

Primary endpoints

• {"endpoint_text":"- Defined at 90 days after inclusion by: All-cause mortality, or recurrence of graft pyelonephritis, or readmission for any cause after hospital discharge for the episode of pyelonephritis.","definition_or_measurement_approach":"Composite endpoint assessed at 90 days after inclusion composed of: all-cause mortality, recurrence of graft pyelonephritis, or readmission for any cause after hospital discharge for the index pyelonephritis episode. Measured by clinical records and follow-up to day 90."}

Secondary endpoints

• {"endpoint_text":"- Total days of antibiotics since diagnosis of graft pyelonephritis.","definition_or_measurement_approach":"Measured as cumulative days of any antibiotic therapy from diagnosis until end of episode."}
• {"endpoint_text":"- Total days of intravenous antibiotics since diagnosis of graft pyelonephritis.","definition_or_measurement_approach":"Measured as cumulative days of IV antibiotic therapy from diagnosis."}
• {"endpoint_text":"- Total days of admission since diagnosis of graft pyelonephritis.","definition_or_measurement_approach":"Measured as total hospital inpatient days from diagnosis."}
• {"endpoint_text":"- Number of adverse events and interactions with concomitant treatments during hospitalization and at 90 days after the patient's inclusion in the study.","definition_or_measurement_approach":"AE collection during admission and up to 90 days post-inclusion; includes recorded interactions with concomitant (e.g., immunosuppressive) treatments."}
• {"endpoint_text":"- Episodes of catheter-related adverse events during admission and at 90 days after the patient's inclusion in the study.","definition_or_measurement_approach":"Recorded catheter-related complications during admission and up to 90 days post-inclusion (e.g., phlebitis)."}
• {"endpoint_text":"- Episodes of Clostridioides difficile at 90 days after the patient's inclusion in the study.","definition_or_measurement_approach":"Documented episodes of C. difficile infection within 90 days of inclusion."}
• {"endpoint_text":"- Evolution of renal function at 90 days from the patient's inclusion in the study.","definition_or_measurement_approach":"Assessment of renal function (e.g., creatinine, eGFR) changes from baseline to day 90."}
• {"endpoint_text":"- Episodes of rejection and graft loss within 90 days of the patient's inclusion in the study.","definition_or_measurement_approach":"Recorded episodes of graft rejection or graft loss within 90 days post-inclusion."}
• {"endpoint_text":"- Isolated microorganisms and antibiotic sensitivity in control urine cultures at 30 and 90 days after the patient's inclusion in the study.","definition_or_measurement_approach":"Microbiology results from control urine cultures at day 30 and day 90, including organism identification and susceptibility profiles."}

Spain

Earliest CTIS Part Ii Submission Date

28-01-2026

Latest Decision Or Authorization Date

02-03-2026

Processing Time Days

33

Number Of Sites

8

Number Of Participants

360

Primary sponsor

Full Name

Bellvitge University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain

Co-sponsors

• Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL