Status:
COMPLETED
Comparison of Two Antimicrobial Therapy Duration for Spondylodiscitis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Vertebral Osteomyelitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Duration of antimicrobial therapy for spondylodiscitis is not standardized; it could vary from 6 weeks to several months depending on the medical habits. The study hypothesis is that a 6 weeks antimic...
Detailed Description
In France, incidence of spondylodiscitis is between 1000 and 1500 new cases a year. Micro-organisms mainly in cause are: Staphylococcus aureus, negative coagulase Staphylococcus, Gram negative bacilli...
Eligibility Criteria
Inclusion
- men or women more than 18 years
- proved bacterial spondylodiscitis due to pyogenic germ (no mycobacteria, no fungus or brucella), for which is decided a treatment antibiotic
- diagnosis is based on clinical,radiological and microbiological criteria
- women in age to procreate, use of an effective contraception with protected sexual relations and negative pregnancy test (b HCG).
Exclusion
- infection with no bacteriological identification
- infection due to mycobacteria, brucella or fungus
- presence of material
- recurrence of spondylodiscitis
- Patient whose life expectation is 1-year-old subordinate
- pregnant or breast-feeding Woman
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
351 Patients enrolled
Trial Details
Trial ID
NCT00764114
Start Date
November 1 2006
End Date
April 1 2013
Last Update
May 6 2013
Active Locations (1)
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1
Chu Raymond Poincare
Garches, France, 92380