Prospective Study in the Emergency

NCT01628900 | Terminated Phase 2

• 1 other identifier: AOM 10103
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Pyelonephritis

Keywords

pyelonephritis; Infection; Antibiotic treatment

Outcome Measures

Primary Outcomes (1)

• The overall cure rate.

  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.

  50 months

Secondary Outcomes (3)

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

  50 months

• 2) Evaluation in the PNA-3 category

  50 months

• 3)For the three categories

  50 months

Study Arms (2)

ambulatory

ACTIVE COMPARATOR

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; Other: Care management

hospitalisation

ACTIVE COMPARATOR

7 days for mono-antibiotherapy at hospital.

Other: care management arm N°1 vs arm N°2; Other: Care management

Interventions

care management arm N°1 vs arm N°2 OTHER

7 days for mono-antibiotherapy at hospital

ambulatory; hospitalisation

Care management OTHER

Hospital vs home

ambulatory; hospitalisation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Ambroise Paré

Boulogne-Billancourt, Île-de-France Region, 92100, France

Location

MeSH Terms

Conditions

Pyelonephritis; Infections

Condition Hierarchy (Ancestors)

Nephritis, Interstitial; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pyelitis; Male Urogenital Diseases

Study Officials

• David Elkharrat, MD

  Hospital Ambroise Paré Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: June 27, 2012
• Study Start: May 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 8, 2013

Record last verified: 2011-06

Locations

FR (1)