Efficacy and Safety Study of Short-term Antibiotic for Pyelonephritis in Women
Primary Purpose
Acute Uncomplicated Pyelonephritis
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Ceftriaxone
Sponsored by
About this trial
This is an interventional treatment trial for Acute Uncomplicated Pyelonephritis focused on measuring Acute Uncomplicated Pyelonephritis, Short-term antibiotic, Ceftriaxone, Cefixime, Women, Efficacy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- CHU de Clermont-Ferrand
Outcomes
Primary Outcome Measures
Microbiological cure at the 9th day
Secondary Outcome Measures
Microbiological cure 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
Full Information
NCT ID
NCT01390623
First Posted
July 7, 2011
Last Updated
July 4, 2014
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT01390623
Brief Title
Efficacy and Safety Study of Short-term Antibiotic for Pyelonephritis in Women
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Uncomplicated Pyelonephritis
Keywords
Acute Uncomplicated Pyelonephritis, Short-term antibiotic, Ceftriaxone, Cefixime, Women, Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone
Intervention 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.
Primary Outcome Measure Information:
Title
Microbiological cure at the 9th day
Time Frame
at the 9th day
Secondary Outcome Measure Information:
Title
Microbiological cure at the 3 rd day
Time Frame
at the 3 rd day
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry MATHEVON
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
26903277
Citation
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.
Results Reference
derived
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Efficacy and Safety Study of Short-term Antibiotic for Pyelonephritis in Women
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