Clinical Trial: Prospective Study in the Emergency

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: New Prognostic Classification of Acute Pyelonephritis With Adaptation of the Therapeutic. Prospective Randomized Study in the Emergency

Brief Summary: The prevalence of acute pyelonephritis (PNA) is 60-75 000/year. They are traditionally classified as uncomplicated (60-65%) and complicated. If it is assumed that the uncomplicated PNA can be treated as outpatients with a cure rate of over 80%, the second group is very heterogeneous. Some patients are severely infected. But others, despite an older age, structural urologic abnormalities or a controlled history, have no risk factors and can be simply managed. The investigators propose to reclassify the PNA into 3 categories: uncomplicated PNA (PNA-1), the PNA of moderate severity (PNA-2), the major PNA (PNA-3) to test whether the PNA-2 can benefit from the same outpatient care that the PNA-1. The existence of biological markers of the severity of bacterial infections would further support a tailored approach. The pro-adrenomedullin (pro-ADM), successfully tested to identify severe community acquired pneumonia, is a an interesting candidate.

Detailed Summary:

In Europe and North America, urinary tract infections (UTI) are the 2nd largest community-acquired infections. In the U.S., the number of annual doctor's consultations for UTI is estimated at 8 million and that of women's APN to 250,000. In Britain, an estimated number of 62 of 1000 women consult for UTI annually. Extrapolated to France, these figures would be 5-6 million annual consultations and 60 to 75 000 APN.

APN is an infection associated with urinary and pelvic and / or the renal parenchyma, marked by fever ≥ 38.5 ° C, spontaneous pain flank, pain caused to the cost vertebral angle and a positive urine dipstick (BU). Conversely, pain and fever can be reduced and 30% of PNA is as cystitis, a history of PNA is then so evocative.

Without a precise technology to detect possible renal micro-abscesses, scars of any APN, direct evidence of upper tract infection is rarely made. Positive blood cultures (30-50%of cases) are indirect evidence. In most cases, only infection of urine is affirmed by cyto-bacteriological examination (urinalysis), which results are available 48-72 hours after culturing. It is assumed that urine culture is positive when leukocyte's count is ≥ 104 cells per milliliter (GB / ml) and bacteriuria ≥ 105 colony forming unit (CFU) / ml of urine (maximum two) uropathogen germ. Therefore, diagnosis and treatment of PNA are probabilistic in the beginning, hence the interest of the BU. It is considered positive when the leukocyte count is ≥ 10 ± GB/mm3 with ± nitriturie. Done correctly, it has a positive predictive value (PPV) of 74% and NPV of 98%.

Classically there are two types of PNA, the complicated PNA and the non-complicated PNA, opposed by age, sex, severity, causative organisms and their sensitivity to antibiotics
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: The overall cure rate. [ Time Frame: 50 months ]

This is the clinical and bacteriological cure, defined by apyrexia, the disappearance of pain and bacteriuria <103 CFU / ml at the 3 follow-up consultations till 45 ± 3 days after the first day of inclusion (day 0), 6 weeks tracking in total.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 1) Evaluation in the two arms of the PNA-2 and PNA-1 classes [ Time Frame: 50 months ]

    Evaluation in the two arms of the PNA-2 and PNA-1 classes:

    • The rate of complications related to the strategy, including aggravation of infection and initial misdiagnosis
    • Changes and duration of antibiotic therapy
    • The rate of secondary hospitalizations
    • The recovery time of the previous activity
    • Rates of pro-ADM
  • 2) Evaluation in the PNA-3 category [ Time Frame: 50 months ]
    In the PNA-3 category: duration of antibiotic therapy and hospitalization.
  • 3)For the three categories [ Time Frame: 50 months ]
    For the three categories: evidence of association between clinical symptoms, history, age and sex, the rate of pro-ADM and healing to construct a prognostic score.


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: May 14, 2012
Date Started: May 2012
Date Completion:
Last Updated: October 7, 2013
Last Verified: June 2011