Comparison of Two Antimicrobial Therapy Duration for Spondylodiscitis (DTS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00764114
First received: September 30, 2008
Last updated: May 3, 2013
Last verified: February 2011

September 30, 2008
May 3, 2013
November 2006
August 2012   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00764114 on ClinicalTrials.gov Archive Site
  • 1)Effective antibiotherapy duration [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • 2) Failure rate at 6 month [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • 3)Rachidial pains (clinical examination and analogical visual scale of the pain) at every visit [ Time Frame: 6 an 12 month ] [ Designated as safety issue: Yes ]
  • 4)Quality of life by the score EQ-5D at 6 and 12 month [ Time Frame: 6 and 12 month ] [ Designated as safety issue: Yes ]
  • 5)Observance of the treatment measured at every visit [ Time Frame: 6 and 12 month ] [ Designated as safety issue: Yes ]
  • 6)Appearance of microbial resistances estimated by comparison of antibiogram in case of failure [ Time Frame: during 12 months ] [ Designated as safety issue: Yes ]
  • 7)Antimicrobial therapy tolerance measure at each visit [ Time Frame: 6 and 12 month ] [ Designated as safety issue: Yes ]
  • 8)Identification of risk factors for failure [ Time Frame: during 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparison of Two Antimicrobial Therapy Duration for Spondylodiscitis
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Vertebral Osteomyelitis
Drug: antibiotic
6 or 12 weeks
Other Name: antibiotic
  • Active Comparator: 1
    - group A : during 6 weeks after the inclusion
    Intervention: Drug: antibiotic
  • Active Comparator: 2
    -group B : during 12 weeks after the inclusion
    Intervention: Drug: antibiotic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
351
April 2013
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00764114
P050607-AOM05031
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Louis Bernard, PU-PH Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP