Acute Uncomplicated PyelonephritisPhase 4NCT01390623
Efficacy and Safety Study of Short-term Antibiotic for Pyelonephritis in Women
A Phase 4 study testing Ceftriaxone in people with Acute Uncomplicated Pyelonephritis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Urinary tract community infections are one of very frequent reason consultation and prescription. Urinary tract represents the second site of bacterial community infection after the respiratory system. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Acute Uncomplicated Pyelonephritis
- What is being tested?
- Ceftriaxone
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between 18 and 65 years old
- Diagnosis of Acute Uncomplicated Pyelonephritis
- Patient obliged to participate in the French national health and pensions system.
- Patient who have read, understood and signed the consent
Who cannot join
- Women who are pregnant
- Men
- One of these risk factor who define a complicated pyelonephritis:
- Medical history of uro-nephrology problem Nephropathy Obstructive Uropathy Vesicoureteral reflux Post mictinal residue > 100mL Urinary fistula Catheter vesicle and urethral Kidney transplantation Immunodeficiency Diabetes
- Recurrent pyelonephritis
- Allergy of betalactam or cephalosporin
Show all 12Show fewer
- History of hypersensitivity reactions to antibiotic medications
- Patient in terminal care
- Trouble of cognitive function
- Patient deprive of judicial or administrative freedom
- Patient participating to another trial
- Refusal to participate to the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety Study of Short Term Antibiotic During Seven Days With Ceftriaxone Intravenous the First Day Then Cefixime the Second Day Till the Seventh Day of Acute Uncomplicated Pyelonephritis in Women Between 18 and 65 Years Old
Urinary tract community infections are one of very frequent reason consultation and prescription. Urinary tract represents the second site of bacterial community infection after the respiratory system. The management of the acute uncomplicated pyelonephritis was simply codified in the past recommendations of the French Agency for Safety Health Products (AFSSAPS) in 2008. Treatment is based on two main families of antibiotics, fluoroquinolones with 7 days treatment and 3rd generation cephalosporins with 10 to 14 days treatment.
The practice of a short treatment with ceftriaxone intra venous relayed by cefixime orally provides a simplified treatment for patients, a reduced use of fluoroquinolones and a probable decrease in correlation with the emergence of fluoroquinolones resistance, and finally, a decrease in the cost of treatment of acute uncomplicated pyelonephritis.
Read the detailed description
Patients will be included by investigators or coinvestigateurs, the day of consultation in the emergency adult department in Clermont-Ferrand city.
The diagnosis of acute uncomplicated pyelonephritis is established in the emergency department based on the clinical, laboratory and imaging criteria.
Clinical, biological and radiological data will gathered during this consultation :
- Clinical data: flank pain, fever, urinary symptoms,
- Biological data: urine dipstick (BU No. 1), cytobacteriological urinary (ECBU No. 1), blood prélèvements (Blood count, creatinine, CRP)
- Imagery: renal and bladder ultrasound. During the next consultations in the emergency department, respectively on day 3 (J3) of treatment and on day 9 (J9), urine tests (urinary dipsticks [BU No. 2 and No. 3] and cytobacteriological urinary [ECBU No. 2 and No. 3] will be realised. The clinical and biological management of patient will be performed by the same department to ensure a better comparability of biological results and a centralized real-time clinical data.
Patient follow-up will end with a phone call on day 37 (J37), and the rate of clinical relapses and / or biological occurred between day 9 and day 37.
- Conditions
- Acute Uncomplicated Pyelonephritis
- Being tested
- Ceftriaxone
- Keywords
- Acute Uncomplicated Pyelonephritis, Short-term antibiotic, Ceftriaxone, Cefixime, Women, Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftriaxoneDrug
Patients will be included by investigators or coinvestigateurs, the day of consultation in the emergency adult department in Clermont-Ferrand city.
The diagnosis of acute uncomplicated pyelonephritis is established in the emergency department based on the clinical, laboratory and imaging criteria.
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological cure at the 9th day
Measured: at the 9th day
Secondary outcomes (2)
Microbiological cure at the 3 rd day
Measured: at the 3 rd day
Number of recurrence of acute pyelonephritis during the month after the treatment between the 9 th and the 37 th day
Measured: between the 9 th and the 37 th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Uncomplicated PyelonephritisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry MATHEVON, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390623
- Sponsor's protocol ID
- CHU-0098
- Other IDs
- 2010-023697-39
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2011
- Last updated
- 3 Aug 2026
- Results posted
- No
Publications
Moustafa F, Nguyen G, Mathevon T, Baud O, Saint-Denis J, Dublanchet N, Pereira B, Shinjo C, Romaszko JP, Dopeux L, Dutheil F, Schmidt J. Evaluation of the efficacy and tolerance of a short 7 day third-generation cephalosporin treatment in the management of acute pyelonephritis in young women in the emergency department. J Antimicrob Chemother. 2016 Jun;71(6):1660-4. doi: 10.1093/jac/dkw021. Epub 2016 Feb 21.
PubMed 26903277
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Short Term Antibiotic During Seven Days With Ceftriaxone Intravenous the First Day Then Cefixime the Second Day Till the Seventh Day of Acute Uncomplicated Pyelonephritis in Women Between 18 and 65 Years Old
- ClinicalTrials.gov ID
- NCT01390623
- Acronym / sponsor ID
- CHU-0098
- Conditions
- Acute Uncomplicated Pyelonephritis
- Keywords
- Acute Uncomplicated Pyelonephritis, Short-term antibiotic, Ceftriaxone, Cefixime, Women, Efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Jul 2011 (estimated)
- 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.
Urinary tract community infections are one of very frequent reason consultation and prescription. Urinary tract represents the second site of bacterial community infection after the respiratory system. The management of the acute uncomplicated pyelonephritis was simply codified in the past recommendations of the French Agency for Safety Health Products (AFSSAPS) in 2008. Treatment is based on two main families of antibiotics, fluoroquinolones with 7 days treatment and 3rd generation cephalosporins with 10 to 14 days treatment.
The practice of a short treatment with ceftriaxone intra venous relayed by cefixime orally provides a simplified treatment for patients, a reduced use of fluoroquinolones and a probable decrease in correlation with the emergence of fluoroquinolones resistance, and finally, a decrease in the cost of treatment of acute uncomplicated pyelonephritis.
Detailed description
Patients will be included by investigators or coinvestigateurs, the day of consultation in the emergency adult department in Clermont-Ferrand city.
The diagnosis of acute uncomplicated pyelonephritis is established in the emergency department based on the clinical, laboratory and imaging criteria.
Clinical, biological and radiological data will gathered during this consultation :
- Clinical data: flank pain, fever, urinary symptoms,
- Biological data: urine dipstick (BU No. 1), cytobacteriological urinary (ECBU No. 1), blood prélèvements (Blood count, creatinine, CRP)
- Imagery: renal and bladder ultrasound. During the next consultations in the emergency department, respectively on day 3 (J3) of treatment and on day 9 (J9), urine tests (urinary dipsticks [BU No. 2 and No. 3] and cytobacteriological urinary [ECBU No. 2 and No. 3] will be realised. The clinical and biological management of patient will be performed by the same department to ensure a better comparability of biological results and a centralized real-time clinical data.
Patient follow-up will end with a phone call on day 37 (J37), and the rate of clinical relapses and / or biological occurred between day 9 and day 37.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women between 18 and 65 years old
- Diagnosis of Acute Uncomplicated Pyelonephritis
- Patient obliged to participate in the French national health and pensions system.
- Patient who have read, understood and signed the consent
Key exclusion criteria (12 listed)
- Women who are pregnant
- Men
- One of these risk factor who define a complicated pyelonephritis:
- Medical history of uro-nephrology problem Nephropathy Obstructive Uropathy Vesicoureteral reflux Post mictinal residue > 100mL Urinary fistula Catheter vesicle and urethral Kidney transplantation Immunodeficiency Diabetes
- Recurrent pyelonephritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeftriaxonePatients will be included by investigators or coinvestigateurs, the day of consultation in the emergency adult department in Clermont-Ferrand city. The diagnosis of acute uncomplicated pyelonephritis is established in the emergency department based on the clinical, laboratory and imaging criteria. | Drug | – |
Primary outcome
Microbiological cure at the 9th day
Time frame: at the 9th day
2 secondary outcomes
Microbiological cure at the 3 rd day
Time frame: at the 3 rd day
Number of recurrence of acute pyelonephritis during the month after the treatment between the 9 th and the 37 th day
Time frame: between the 9 th and the 37 th day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Results publication: PubMed 26903277Moustafa F, Nguyen G, Mathevon T, Baud O, Saint-Denis J, Dublanchet N, Pereira B, Shinjo C, Romaszko JP, Dopeux L, Dutheil F, Schmidt J. Evaluation of the efficacy and tolerance of a short 7 day third-generation cephalosporin treatment in the management of acute pyelonephritis in young women in the emergency department. J Antimicrob Chemother. 2016 Jun;71(6):1660-4. doi: 10.1093/jac/dkw021. Epub 2016 Feb 21.
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.
Thierry MATHEVON principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceftriaxone in people with Acute Uncomplicated Pyelonephritis, run by University Hospital, Clermont-Ferrand 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 3 Aug 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Microbiological cure at the 9th day (time frame: at the 9th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01390623, which also lists 1 linked publication.
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 3 Aug 2026.