Clinical Trial: Efficacy and Safety Study of Short-term Antibiotic for Pyelonephritis in Women

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 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 Summary:

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.


Sponsor: University Hospital, Clermont-Ferrand

Current Primary Outcome: Microbiological cure at the 9th day [ Time Frame: at the 9th day ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Clermont-Ferrand

Dates:
Date Received: July 7, 2011
Date Started: July 2011
Date Completion:
Last Updated: July 4, 2014
Last Verified: July 2014