Acute Uncomplicated Pyelonephritis Clinical Trial
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00239161 -
Safety and Efficacy Study of the Treatment of Kidney Infections With Short Course Levofloxacin
|
Phase 4 |