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Prospective Study in the Emergency (PROPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01628900
Recruitment Status : Terminated
First Posted : June 27, 2012
Last Update Posted : October 8, 2013
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Pyelonephritis Other: care management arm N°1 vs arm N°2 Other: Care management Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: New Prognostic Classification of Acute Pyelonephritis With Adaptation of the Therapeutic. Prospective Randomized Study in the Emergency
Study Start Date : May 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Active Comparator: ambulatory
Patient will be treated for 7 days at home, then 3 follow-up visit at hospital.
Other: care management arm N°1 vs arm N°2
7 days for mono-antibiotherapy at hospital

Other: Care management
Hospital vs home

Active Comparator: hospitalisation
7 days for mono-antibiotherapy at hospital.
Other: care management arm N°1 vs arm N°2
7 days for mono-antibiotherapy at hospital

Other: Care management
Hospital vs home

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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. 2) Evaluation in the PNA-3 category [ Time Frame: 50 months ]
    In the PNA-3 category: duration of antibiotic therapy and hospitalization.

  3. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01628900

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Hôpital Ambroise Paré
Boulogne Billancourt, Ile de France, France, 92100
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: David Elkharrat, MD Hospital Ambroise Paré Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01628900     History of Changes
Other Study ID Numbers: AOM 10103
First Posted: June 27, 2012    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: June 2011
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Antibiotic treatment
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes
Nephritis, Interstitial
Kidney Diseases
Urologic Diseases