Clinical trial · Interventional
Comparison of Two Antimicrobial Therapy Duration for Spondylodiscitis
Comparison of Two Antimicrobial Therapy Duration (6 Weeks Versus 12 Weeks)for Spondylodiscitis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vertebral Osteomyelitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| antibiotic | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- \- group A : during 6 weeks after the inclusion
- interventionNames
- Drug: antibiotic
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- -group B : during 12 weeks after the inclusion
- interventionNames
- Drug: antibiotic
Primary outcomes (1)
- 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.
- timeFrame
- 1 year after the stop of the treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDDesoutter S, Cottier JP, Ghout I, Issartel B, Dinh A, Martin A, Carlier R, Bernard L; Duration of Treatment for Spondylodiscitis Study Group. Susceptibility Pattern of Microorganisms Isolated by Percutaneous Needle Biopsy in Nonbacteremic Pyogenic Vertebral Osteomyelitis. Antimicrob Agents Chemother. 2015 Dec;59(12):7700-6. doi: 10.1128/AAC.01516-15. Epub 2015 Oct 5. PMID 26438497
- DERIVEDZervou FN, Zacharioudakis IM, Mylonakis E. ACP Journal Club. 6 weeks of antibiotics was noninferior to 12 weeks for clinical cure in pyogenic vertebral osteomyelitis. Ann Intern Med. 2015 May 19;162(10):JC7. doi: 10.7326/ACPJC-2015-162-10-007. No abstract available. PMID 25984880
- DERIVEDBernard L, Dinh A, Ghout I, Simo D, Zeller V, Issartel B, Le Moing V, Belmatoug N, Lesprit P, Bru JP, Therby A, Bouhour D, Denes E, Debard A, Chirouze C, Fevre K, Dupon M, Aegerter P, Mulleman D; Duration of Treatment for Spondylodiscitis (DTS) study group. Antibiotic treatment for 6 weeks versus 12 weeks in patients with pyogenic vertebral osteomyelitis: an open-label, non-inferiority, randomised, controlled trial. Lancet. 2015 Mar 7;385(9971):875-82. doi: 10.1016/S0140-6736(14)61233-2. Epub 2014 Nov 5. PMID 25468170