New Prognostic Classification of Acute Pyelonephritis With Adaptation of the Therapeutic. Prospective Randomized Study in the Emergency
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- The overall cure rate.
Study Overview
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 Description
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.
Uncomplicated PNA is the best defined. It occurs on a normal urinary tract in nonpregnant women, aged 15 to 65, with no systemic disease or urological surgery. It is not accompanied with by septic shock or renal abscesses. It is due to E. Coli in 90% of cases, sometimes to Klebsiella and Proteus sp, all susceptible to recommended antibiotics.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •man or woman
- •age ≥ 18 years
- •signed a written informed consent
- •Social security coverage
- •have all the necessary signs for a PNA diagnosis
- •whose ranking to PNA-1, PNA or PNA-2-3 is possible
- •Fever ≥ 38.5 ° C
- •Or the possibility of hypothermia in the single case of PNA-3
- •Of a spontaneous pain of one or both sides
- •Pain caused to the costovertebral angle
- •And presence of leukocyturia GB/mm3 ≥ 10 with or without nitriturie
- •Imaging examination at least abdominopelvic ultrasound (EAP) or CT, excluding any other possible diagnoses
Exclusion Criteria
- •Pregnant or lactating women because they are also mother-child care
- •Patients refusing to provide reliable contact information, especially phone number
- •In general, patients with significant cognitive impairment, no entourage, because adherence to guidelines, treatment and monitoring can be very random
- •The PNA 3 emergency situation such as no time to start antibiotics ("antibiotic Emergency" = 30 to 60 minutes between arrival and administration of antibiotics) or reanimation can not be accepted, especially if a third person was required to sign the consent. The typical example is the patient with septic shock.
- •Inclusion in another study,
- •Any suspected nosocomial PNA, defined as any PNA appeared within 48 hours of discharge from a medical institution. The residential facilities for the frail elderly (retirement homes), and other institutions for the aged, not medicalized, are not affected by this limitation.
- •All uptake within 24 hours of: ciprofloxacin, ofloxacin, levofloxacin, or ceftriaxone.
- •Taking antibiotics considered less active in E. coli (amoxicillin ± clavulanate, trimethoprim) or ineffective in the pna (norfloxacin), before arriving at the hospital regardless of its duration, is not an exclusion criteria. The approach should remain similar to those of other patients, and possible exclusion imposed only if the initial bacteriuria is ≤ 103 CFU / ml.
Arms & Interventions
ambulatory
Patient will be treated for 7 days at home, then 3 follow-up visit at hospital.
Intervention: care management arm N°1 vs arm N°2 (Other)
ambulatory
Patient will be treated for 7 days at home, then 3 follow-up visit at hospital.
Intervention: Care management (Other)
hospitalisation
7 days for mono-antibiotherapy at hospital.
Intervention: care management arm N°1 vs arm N°2 (Other)
hospitalisation
7 days for mono-antibiotherapy at hospital.
Intervention: Care management (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 2) Evaluation in the PNA-3 category(50 months)
- 1) Evaluation in the two arms of the PNA-2 and PNA-1 classes(50 months)
- 3)For the three categories(50 months)