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NCT Number: NCT06848816

Duration of Antibiotic Therapy in Acute Kidney Graft Pyelonephritis (AGPN): 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nancy

Nancy, 54000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Relaspe AGPN

    Time frame: 3 month

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

Secondary outcomes

  1. Early AGPN relapse

    Time frame: 1 month

    Rehospitalization for acute kidney graft pyelonephritis (AGPN) within one month after completion of treatment

  2. ITU relapse

    Time frame: 3 month

    Antibiotic treatment for urinary tract infection within 3 months after completion of treatment.

  3. Identical microorganism relapsing AGPN

    Time frame: 3 month

    New episode of AGPN with the same pathogen within 3 months after completion of treatment

  4. Multidrug resistant emerging pathogens

    Time frame: 3 month

    Infection with a multidrug-resistant bacteria within 3 months after completion of treatment

  5. Clostridioides difficile colitis

    Time frame: 3 month

    Occurrence of Clostridioides difficile colitis within 3 months after completion of treatment

  6. Early kidney function evolution

    Time frame: 1 month

    Evolution of renal function (creatininemia) 1 month after completion of treatment for APNAG.

  7. 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

  8. Risk factors

    Time frame: 3 month

    Clinical and biological Factors associated with AGPN recurrence independently of the duration of antibiotic therapy

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: DUTRAPYL

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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