Text Size

Prospective Study in the Emergency (PROPA)

This study is currently recruiting participants.
Verified June 2011 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01628900
First received: May 14, 2012
Last updated: October 12, 2012
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Pyelonephritis
 Other: care management arm N°1 vs arm N°2
Other: Care management
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: New Prognostic Classification of Acute Pyelonephritis With Adaptation of the Therapeutic. Prospective Randomized Study in the Emergency

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • The overall cure rate. [ Time Frame: 50 months ] [ Designated as safety issue: Yes ]
    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) Evaluation in the two arms of the PNA-2 and PNA-1 classes [ Time Frame: 50 months ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    In the PNA-3 category: duration of antibiotic therapy and hospitalization.

  • 3)For the three categories [ Time Frame: 50 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 600
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628900

Contacts
Contact: David Elkharrat, MD 00 33 1 49 09 59 38 david.elkharrat@apr.aphp.fr

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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01628900     History of Changes
Other Study ID Numbers: AOM 10103
Study First Received: May 14, 2012
Last Updated: October 12, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
pyelonephritis
Infection
Antibiotic treatment

Additional relevant MeSH terms:
Emergencies
Pyelonephritis
Disease Attributes
Pathologic Processes
Nephritis, Interstitial
 Nephritis
Kidney Diseases
Urologic Diseases
Pyelitis

ClinicalTrials.gov processed this record on June 17, 2013