Clinical Trial: Comparison of Two Antimicrobial Therapy Duration for Spondylodiscitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Comparison of Two Antimicrobial Therapy Duration (6 Weeks Versus 12 Weeks)for Spondylodiscitis
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 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.
Detailed Summary:
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 effecti
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: 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. [ Time Frame: 1 year after the stop of the treatment. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 1)Effective antibiotherapy duration [ Time Frame: 12 months ]
- 2) Failure rate at 6 month [ Time Frame: 6 months ]
- 3)Rachidial pains (clinical examination and analogical visual scale of the pain) at every visit [ Time Frame: 6 an 12 month ]
- 4)Quality of life by the score EQ-5D at 6 and 12 month [ Time Frame: 6 and 12 month ]
- 5)Observance of the treatment measured at every visit [ Time Frame: 6 and 12 month ]
- 6)Appearance of microbial resistances estimated by comparison of antibiogram in case of failure [ Time Frame: during 12 months ]
- 7)Antimicrobial therapy tolerance measure at each visit [ Time Frame: 6 and 12 month ]
- 8)Identification of risk factors for failure [ Time Frame: during 12 months ]
Original Secondary Outcome: Same as current
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: September 30, 2008
Date Started: November 2006
Date Completion:
Last Updated: May 3, 2013
Last Verified: February 2011
