NCT06848816

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

5.3 years

First QC Date

February 16, 2025

Last Update Submit

February 21, 2025

Conditions

Pyelonephritis AcuteKidney Transplantation Recipients

Keywords

Acute graft pyelonephritisduration treatmentantibioticrecurrencerelapse

Outcome Measures

Primary Outcomes (1)

  • Relaspe AGPN

    Rehospitalization for acute kidney graft pyelonephritis (AGPN) within three months after completion of treatment

    3 month

Secondary Outcomes (8)

  • Early AGPN relapse

    1 month

  • ITU relapse

    3 month

  • Identical microorganism relapsing AGPN

    3 month

  • Multidrug resistant emerging pathogens

    3 month

  • Clostridioides difficile colitis

    3 month

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Every patient with AGPN during the study period

You may qualify if:

  • Adult patients
  • Kidney transplant recipients with a functional graft.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nancy

Nancy, 54000, France

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

February 16, 2025

First Posted

February 27, 2025

Study Start

January 1, 2020

Primary Completion

April 30, 2025

Study Completion

December 31, 2025

Last Updated

February 27, 2025

Record last verified: 2025-02

Locations

FR(1)