Comparison of Two Antimicrobial Therapy Duration for Spondylodiscitis

NCT00764114 | Completed Phase 4 DMC

• 1 other identifier: P050607-AOM05031
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertebral Osteomyelitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

\- group A : during 6 weeks after the inclusion

Drug: antibiotic

2

ACTIVE COMPARATOR

-group B : during 12 weeks after the inclusion

Drug: antibiotic

Interventions

antibiotic DRUG

6 or 12 weeks

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Chu Raymond Poincare

Garches, 92380, France

Location

Related Publications (3)

• Desoutter 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 DERIVED

• Zervou 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 DERIVED

• Bernard 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 DERIVED

MeSH Terms

Conditions

Discitis; Multiple Endocrine Neoplasia Type 1

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Spondylitis; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Louis Bernard, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 1, 2008
• Study Start: November 1, 2006
• Primary Completion: August 1, 2012
• Study Completion: April 1, 2013
• Last Updated: May 6, 2013

Record last verified: 2011-02

Locations

FR (1)