Duration of Antibiotic Therapy in Acute Kidney Graft Pyelonephritis (AGPN): Effect on the Risk of Recurrence (DUTRAPYL)

February 21, 2025 updated by: CORBEL Alice, Central Hospital, Nancy, France

DUTRAPYL STUDY : Duration of Antibiotic Therapy in Acute Kidney Graft Pyelonephritis: Effect on the Risk of Recurrence

The aim of this study is to evaluate the impact of the duration of antibiotic therapy on the risk of recurrence in kidney graft pyelonephritis. The secondary objectives are to identify the factors associated with the duration of antibiotic therapy in acute kidney graft pyelonephritis, identify the factors associated with recurrence of acute kidney graft pyelonephritis within 3 months, evaluate the impact of the duration of antibiotic therapy on antibiotic-related complications and assess the impact of the duration of antibiotic therapy on the progression of renal function after acute kidney graft pyelonephritis.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
        • CHU de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Every patient with AGPN during the study period

Description

Inclusion Criteria:

  • Adult patients
  • Kidney transplant recipients with a functional graft.
  • Hospitalization with acute pyelonephritis (APN) defined by fever OR chills (noted in the clinical records) AND bacteriuria AND exclusion of another obvious cause of fever. (For rehospitalizations, also include cases where antibiotic therapy was initiated based on suspicion, even in the absence of documented infection.)

Exclusion Criteria:

  • Age < 18 years.
  • Vacationing patient or lost to follow-up with follow-up < 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relaspe AGPN
Time Frame: 3 month
Rehospitalization for acute kidney graft pyelonephritis (AGPN) within three months after completion of treatment
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early AGPN relapse
Time Frame: 1 month
Rehospitalization for acute kidney graft pyelonephritis (AGPN) within one month after completion of treatment
1 month
ITU relapse
Time Frame: 3 month
Antibiotic treatment for urinary tract infection within 3 months after completion of treatment.
3 month
Identical microorganism relapsing AGPN
Time Frame: 3 month
New episode of AGPN with the same pathogen within 3 months after completion of treatment
3 month
Multidrug resistant emerging pathogens
Time Frame: 3 month
Infection with a multidrug-resistant bacteria within 3 months after completion of treatment
3 month
Clostridioides difficile colitis
Time Frame: 3 month
Occurrence of Clostridioides difficile colitis within 3 months after completion of treatment
3 month
Early kidney function evolution
Time Frame: 1 month
Evolution of renal function (creatininemia) 1 month after completion of treatment for APNAG.
1 month
3 month kidney function evolution
Time Frame: 3 month and 21 days
Evolution of renal function (creatininemia) 3 +/- 21 days after completion of treatment for AGPN
3 month and 21 days
Risk factors
Time Frame: 3 month
Clinical and biological Factors associated with AGPN recurrence independently of the duration of antibiotic therapy
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 16, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DUTRAPYL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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