DTS: Comparison of Two Antimicrobial Therapy Duration for Spondylodiscitis

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00764114

Collaborator

(none)

351

Enrollment

Location

Arms

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vertebral Osteomyelitis	Drug: antibiotic	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

351 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Two Antimicrobial Therapy Duration (6 Weeks Versus 12 Weeks)for Spondylodiscitis

Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 - group A : during 6 weeks after the inclusion	Drug: antibiotic 6 or 12 weeks
Active Comparator: 2 -group B : during 12 weeks after the inclusion	Drug: antibiotic 6 or 12 weeks

Arm

Intervention/Treatment

Active Comparator: 1

- group A : during 6 weeks after the inclusion

Drug: antibiotic

6 or 12 weeks

Active Comparator: 2

-group B : during 12 weeks after the inclusion

Drug: antibiotic

6 or 12 weeks

Outcome Measures

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. [1 year after the stop of the treatment.]

Secondary Outcome Measures

1)Effective antibiotherapy duration [12 months]
2) Failure rate at 6 month [6 months]
3)Rachidial pains (clinical examination and analogical visual scale of the pain) at every visit [6 an 12 month]
4)Quality of life by the score EQ-5D at 6 and 12 month [6 and 12 month]
5)Observance of the treatment measured at every visit [6 and 12 month]
6)Appearance of microbial resistances estimated by comparison of antibiogram in case of failure [during 12 months]
7)Antimicrobial therapy tolerance measure at each visit [6 and 12 month]
8)Identification of risk factors for failure [during 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).