Study to Find Out Whether a Shorter Antibiotic Treatment (7 Days) Is as Effective and Safe as the Usual One (14 Days) in Patients with an Infection in Their Transplanted Kidney (Kti)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

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

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Decision date (initial)

2026-03-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The primary objective of the study is to demonstrate the non-inferiority of a 7-day treatment regimen compared to 14 days of antibiotic treatments used in usual clinical practice in patients with graft pyelonephritis.

Secondary objectives 12

1. To compare the mortality of patients with graft pyelonephritis on a 7-day antibiotic treatment regimen versus the usual 14-day regimen.
2. To compare the recurrence rate of graft pyelonephritis in patients on a 7-day antibiotic treatment regimen versus the usual 14-day regimen.
3. To compare the readmission rate of patients with graft pyelonephritis receiving a 7-day antibiotic treatment regimen versus the standard 14-day regimen.
4. To determine the total days of antibiotic treatment required from the diagnosis of graft pyelonephritis between the two treatment regimens.
5. To determine the total days of intravenous antibiotics required from the diagnosis of graft pyelonephritis between the two treatment regimens.
6. To determine the total days of hospitalization required from the diagnosis of graft pyelonephritis between the two treatment regimens.
7. To evaluate the safety of antibiotic treatments used and potential interactions with concomitant treatments (immunosuppression) during the episode of acute allograft pyelonephritis.
8. To determine catheter-related adverse effects during the treatment of graft pyelonephritis (e.g., phlebitis).
9. To determine episodes of Clostridioides difficile infection.
10. To assess the evolution of renal function during treatment of the episode of graft pyelonephritis and its evolution.
11. To determine the incidence of graft rejection and loss during treatment of graft pyelonephritis and its outcome.
12. To analyze the antibiotic susceptibility of microorganisms isolated from episodes of urinary tract infection and follow-up urine cultures.

Conditions and MedDRA coding

Graft pyelonephritis in kidney transplant recipients

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. 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.
2. 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 10

1. 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.
2. Patients with known anatomical alterations that predispose to urinary tract infections (such as vesicoureteral reflux or obstructive prostatic hypertrophy).
3. Presence of urinary catheters such as bladder catheters or ureteral catheters.
4. Presence of complications such as urinary obstruction or kidney abscess.
5. Kidney transplant recipients admitted for an episode of graft pyelonephritis in the previous 30 days.
6. Participation in another clinical trial in which the protocol establishes antibiotic treatment for pyelonephritis.
7. Previous inclusion in the present study.
8. No authorization from the patient or their legal representative to sign the informed consent.
9. 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.
10. Pregnant or breastfeeding patients.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 9

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bellvitge University Hospital

Sponsor organisation

Bellvitge University Hospital

Address

Carrer De La Feixa Llarga S/N

City

L'Hospitalet De Llobregat

Postcode

08907

Country

Spain

Scientific contact point

Organisation

Bellvitge University Hospital

Contact name

Núria Sabé Fernández

Public contact point

Organisation

Bellvitge University Hospital

Contact name

Núria Sabé Fernández

Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

Sponsor organisation

Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

Address

Avinguda De La Gran Via De L'hospitalet 199

City

L'Hospitalet De Llobregat

Postcode

08908

Country

Spain

Scientific contact point

Organisation

Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

Contact name

Yaiza Hermoso Gallego

Public contact point

Organisation

Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

Contact name

Yaiza Hermoso Gallego

Sponsor responsibilities

Article 77 compliance

Bellvitge University Hospital

Contact point sponsor

Bellvitge University Hospital

Article 77 implementation

Bellvitge University Hospital

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications