Treatment's Duration of Acute Uncomplicated Pyelonephritis
Condition: Urinary Tract Infection; Fever
MeSH terms: Urinary Tract Infections; Pyelonephritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy of 5 days versus 10 days treatment
      duration in uncomplicated acute pyelonephritis.

      Acute pyelonephritis is a common disease and the treatment duration is not found on
      scientific evidence. If a short treatment is equal to standard duration, it will possible to
      shortening antibiotherapy with ecologic and economic advantage.
    

Detailed description: 
      1. State of the issue and objective of the research The acute pyelonephritis (AP) represent
           the most frequent COMMUNAUTARY bacterial infection. Currently, usual recommended
           duration of antibiotherapy for this disease is from 10 to 21 days. The duration of
           treatment is not based on scientific evidence. Shortening duration of antibiotherapy
           would improve patient's life quality of and compliance and reduce side effects, duration
           of hospitalization, cost of treatment and probably limit bacterial resistance.

           The main objective of this study is to compare the rates of clinical and microbiological
           cure at 30 ± 5 days after the end of antibiotherapy in uncomplicated AP of young women,
           according to the duration of antibiotic treatment: 5 days versus 10 days.

        2. People involved Patients with uncomplicated AP, will be offered to participate to the
           study after consultation in emergency room service or health service, in absence of
           non-inclusion criteria (immunodepression known, severe sepsis, allergy to antibiotics,
           pregnancy, lactation ...). In presence of abscesses, obstruction on the urinary tract,
           or infection on stranger material device requiring, in most cases, a medical-surgical
           treatment, they will not be eligible under the study.

        3. Methods of observation or investigation restraint Non-inferiority multicenter trial,
           randomized in 2 parallel groups evaluating antibiotic treatment (5d vs 10d) in the
           uncomplicated AP.

           Recruitment and follow-up: The management of the patient will initially be provided by
           emergency room department or the hospital clinic. After signing the consent and
           inclusion (J0), the patient will receive an initial assessment, the initiation of
           antibiotic therapy and care. Then it will be:

             -  Either in a hospital service who will follow.

             -  Either by ambulatory monitoring and regularly contacted (phone with voice server)
                to ensure proper development.

           Randomisation will take place in J0. Finally, in all cases, a final visit will be set at
           J30 ± 5Day.

        4. Origin and nature of the data collected - Reasons for them Data for the study duration
           of treatment of pyelonephritis are from information provided by patients. The nature of
           the data include: name, surname, date of birth, medical data (medical history, history
           of the disease, symptoms of infection) and telephone numbers of the patient. The
           collection of these numbers is essential for monitoring the patient.

        5. Method for data flow These data will be confidential and only, the physician
           investigator, the scientific coordinator doctor, the doctor treating the patient and the
           clinical research fellow, will have access to this information. These data will be
           computerized and protected by a personal access code.

        6. Duration and modalities of the research The duration of the research will be a maximum
           of 24 months (the duration is 12 months for inclusion and follow-up of 310 patients).

      Research will multicenter (26 centers at most) and led by principal investigator (Pr. Louis
      Bernard) and the scientific coordinator (Dr. AURELIEN DINH) At the end of the study, all data
      will be destroyed.
    

Intervention name(s): levofloxacin, ciprofloxacin and ofloxacin (fluoroquinolones)
Intervention type(s): Drug
Intervention description(s): Levofloxacin 500mg : 1/j Ofloxacin : 200mgX2/j Ciprofloxacin 500mg X2/j
Other intervention name(s): randomised duration therapy
Intervention MeSH terms: Ciprofloxacin; Levofloxacin; Ofloxacin; Fluoroquinolones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urinary tract infection; treatment duration; acute pyelonephritis; good use of antibiotics