Comparison of Two Antimicrobial Therapy Duration for Spondylodiscitis

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antitubercular

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