Pyelonephritis AcuteDUTRAPYLNCT06848816
Duration of Antibiotic Therapy in Acute Kidney Graft Pyelonephritis (AGPN): Effect on the Risk of Recurrence
An observational study of Pyelonephritis Acute and Kidney Transplantation Recipients, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pyelonephritis Acute, Kidney Transplantation Recipients
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every patient with AGPN during the study period
Who may be able to join
- 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.)
Who cannot join
- Age < 18 years.
- Vacationing patient or lost to follow-up with follow-up < 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- Acute graft pyelonephritis, duration treatment, antibiotic, recurrence, relapse
- Medical subject headings
- Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Relaspe AGPN
Rehospitalization for acute kidney graft pyelonephritis (AGPN) within three months after completion of treatment
Measured: 3 month
Secondary outcomes (8)
Early AGPN relapse
Rehospitalization for acute kidney graft pyelonephritis (AGPN) within one month after completion of treatment
Measured: 1 month
ITU relapse
Antibiotic treatment for urinary tract infection within 3 months after completion of treatment.
Measured: 3 month
Identical microorganism relapsing AGPN
New episode of AGPN with the same pathogen within 3 months after completion of treatment
Measured: 3 month
Multidrug resistant emerging pathogens
Infection with a multidrug-resistant bacteria within 3 months after completion of treatment
Measured: 3 month
Clostridioides difficile colitis
Occurrence of Clostridioides difficile colitis within 3 months after completion of treatment
Measured: 3 month
Early kidney function evolution
Evolution of renal function (creatininemia) 1 month after completion of treatment for APNAG.
Measured: 1 month
3 month kidney function evolution
Evolution of renal function (creatininemia) 3 +/- 21 days after completion of treatment for AGPN
Measured: 3 month and 21 days
Risk factors
Clinical and biological Factors associated with AGPN recurrence independently of the duration of antibiotic therapy
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Jan 2020
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pyelonephritis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CORBEL Alice, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848816
- Sponsor's protocol ID
- DUTRAPYL
- Acronym
- DUTRAPYL
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DUTRAPYL STUDY : Duration of Antibiotic Therapy in Acute Kidney Graft Pyelonephritis: Effect on the Risk of Recurrence
- ClinicalTrials.gov ID
- NCT06848816
- Acronym / sponsor ID
- DUTRAPYL / DUTRAPYL
- Keywords
- Acute graft pyelonephritis, duration treatment, antibiotic, recurrence, relapse
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient with AGPN during the study period
Key inclusion criteria (3 listed)
- 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.)
Key exclusion criteria (2 listed)
- Age < 18 years.
- Vacationing patient or lost to follow-up with follow-up < 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relaspe AGPN
Time frame: 3 month
Rehospitalization for acute kidney graft pyelonephritis (AGPN) within three months after completion of treatment
8 secondary outcomes
Early AGPN relapse
Time frame: 1 month
ITU relapse
Time frame: 3 month
Identical microorganism relapsing AGPN
Time frame: 3 month
Multidrug resistant emerging pathogens
Time frame: 3 month
Clostridioides difficile colitis
Time frame: 3 month
Early kidney function evolution
Time frame: 1 month
3 month kidney function evolution
Time frame: 3 month and 21 days
Risk factors
Time frame: 3 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pyelonephritis Acute and Kidney Transplantation Recipients, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relaspe AGPN (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.