Vertebral Osteomyelitis Clinical Trial
Official title:
Comparison of Two Antimicrobial Therapy Duration (6 Weeks Versus 12 Weeks)for Spondylodiscitis
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 antimicrobial therapy is not inferior to a 12 weeks.
We run a prospective multi-centric, non inferiority open label trial, randomised in two
parallel groups.
The main objective is to compare the efficacy of two durations of antibiotherapy, 6 weeks
versus 12 weeks, on the rate of cure in this indication.
The study concerns 400 patients more than 18 years, 70 centres in France are involved.
The duration of the study is 4 years.
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 and Streptococci; more rarely mycobacteria or
Brucella. Actually, optimal duration of antimicrobial therapy is unclear. The rate of cure
varies, according to studies, from 90 to 100 % whatever the responsible germ involved. If a
6 weeks antimicrobial therapy duration is not inferior to 12, this would allow to shortening
usual antimicrobial therapy duration, and improve tolerance of the treatment, with
ecological and economic benefits, following a politics of good use of antibiotics, defined
in the French circular n°2002-272 of 02/05/02.
The main objective is to compare two durations of antimicrobial therapy, 6 weeks versus 12
weeks, on the rate of cure of the bacterial spondylodiscitis. Secondary objectives are to
compare, according to the duration of treatment antibiotic, 1) Rachidial pain by clinical
examination and an analogical visual scale (EVA), 2) Quality of life by the score EQ-5D, 3)
Treatment tolerance. 4) Risk factors for failure.
Type of the study is Prospective multi-centric, open label trial, randomised in two parallel
groups with direct individual profit.
Antimicrobial therapy is chosen by the physician on charge of the patient according to the
germ and to the consensual recommendations.
The study concerns 400 patients.
Inclusion criteria are : men or women more than 18 years, having a proved bacterial
spondylodiscitis (not mycobacteria, not fungal nor Brucella), for which an antimicrobial
therapy is needed; for the women in age to procreate use of an effective contraception with
protected sexual relations and negative pregnancy test (b HCG) is necessary.
Non Inclusion criteria are: infection with no bacteriological identification or
mycobacteria, fungal or brucellosis infection, presence of material or recurrence of
spondylodiscitis.
Main criterion of evaluation: percentage of success in 1 year defined by the absence of
infection : absence of clinical, biological and radiological signs of infection (pain,
fever) ; or relapse with the same germ.
This criterion will be estimated beyond the first 6 weeks of treatment antibiotic after the
introduction of the treatment and until 1 year after the stop of the treatment. The criteria
of the bacteriological diagnosis will be the same.
Design of the study: patients after information consent signed are include and randomised in
one arm. They are regularly follow (at 1, 2, 3, 6 and 12 weeks after the beginning of
antimicrobial therapy, then at 6 and 12 month after the end of antimicrobial therapy) , with
physical examination, biological tests and radiological acts.
The randomisation is centralized, balanced by block, stratifies by centres. (70 centres) The
previous duration of the study is of 4 years.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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