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
  Purpose

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.


Condition Intervention Phase
Vertebral Osteomyelitis
Drug: antibiotic
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Two Antimicrobial Therapy Duration (6 Weeks Versus 12 Weeks)for Spondylodiscitis

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 351
Study Start Date: November 2006
Study Completion Date: April 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
- group A : during 6 weeks after the inclusion
Drug: antibiotic
6 or 12 weeks
Other Name: antibiotic
Active Comparator: 2
-group B : during 12 weeks after the inclusion
Drug: antibiotic
6 or 12 weeks
Other Name: antibiotic

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764114

Locations
France
Chu Raymond Poincare
Garches, France, 92380
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Louis Bernard, PU-PH Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00764114     History of Changes
Other Study ID Numbers: P050607-AOM05031
Study First Received: September 30, 2008
Last Updated: May 3, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Spondylodiscitis
Duration treatment
Antibiotic
men or women more than 18 years
proved bacterial spondylodiscitis
patient for which is decided a treatment antibiotic
the diagnosis on clinical
Radiological
microbiological criteria

Additional relevant MeSH terms:
Osteomyelitis
Discitis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spondylitis
Spinal Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 18, 2014