SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis

NCT06250023 | Recruiting DMC

• 1 other identifier: 2023-507617-96-01
• Study Type: observational
• Target: 530
• Locations: 1 country
• Sites: 1

Brief Summary

Background The current Danish National Guideline for treatment of pyogenic vertebral osteomyelitis (PVO) recommends 6 weeks antibiotic (AB) treatment, with a 2-week intravenous (IV) AB lead-in followed by 4 weeks oral AB for uncomplicated PVO, and 12 weeks AB treatment with a 2-4-week IV AB lead-in followed by 8 weeks oral AB for complicated PVO. The primary objective of the current study is to investigate whether shortening the duration of IV AB to one week for both complicated and uncomplicated PVO is non-inferior to the current Danish National Guideline.

Conditions

Osteomyelitis; Vertebra

Outcome Measures

Primary Outcomes (5)

• Primary outcome

  All-cause mortality

  Six months after completion of oral antibiotic treatment

• Primary outcome

  Unplanned surgical intervention in relation to the spine

  Six months after completion of oral antibiotic treatment

• Primary outcome

  Relapse of bacteremia with primary pathogen

  Six months after completion of oral antibiotic treatment

• Primary outcome

  Relapse of bacteria with the initial pathogen being cultured from relevant material from infected areas in relation to the spine or iliopsoas muscle (detected by culture)

  Six months after completion of oral antibiotic treatment

• Primary outcome

  Renewed course of intravenous antibiotic given for more than 7 days for treatment of pyogenic vertebral osteomyelitis

  Six months after completion of oral antibiotic treatment

Secondary Outcomes (13)

• Secondary outcome 1

  Six months after completion of oral antibiotic treatment

• Secondary outcome 2

  Six months after completion of oral antibiotic treatment

• Secondary outcome 3

  Six months after completion of oral antibiotic treatment

• Secondary outcome 4

  Six months after completion of oral antibiotic treatment

• Secondary outcome 5

  Six months after completion of oral antibiotic treatment

Study Arms (2)

Standart of care

Standard of care (comparator) * Uncomplicated PVO: 2 weeks IV ABs followed by oral ABs for 4 weeks. * Complicated PVO: 2-4 weeks IV ABs followed by oral ABs for 8 weeks.

Early shift

Early shift to oral ABs (intervention) * Uncomplicated PVO: 1 week IV ABs followed by 5 weeks of oral ABs. * Complicated PVO: 1 week IV ABs followed by 11 weeks of oral ABs.

Other: Early shift til oral antibiotic treatment for osteomyelitis

Interventions

Early shift til oral antibiotic treatment for osteomyelitis OTHER

To investigate whether early transition to oral AB treatment after one week of IV treatment is non-inferior to the current national guideline of continued IV AB treatment for two to four weeks followed by oral AB treatment for PVO.

Early shift

Eligibility Criteria

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

Study Population

The study will be a nationwide, multicenter, investigator initiated, randomized, controlled, parallel group, open label, non-inferiority trial. The study will be conducted at departments of infectious diseases in Denmark and in collaboration with spinal surgery units carrying out infection-related spinal surgery. All patients diagnosed with PVO will be assessed for eligibility. Patients will be eligible for inclusion if they fulfill all the inclusion and none of the exclusion criteria.

You may qualify if:

• Age ≥18 years
• Diagnosed with PVO by a physician based on clinical symptoms and findings consistent with PVO in combination with diagnostic imaging (MRI, PET/CT or PET/MRI)
• The physician responsible for the patient decides to treat the patient for PVO
• At time of randomization CRP has decreased to \< 75% of peak value or to \< 20 mg/l
• At the time of randomization patient has received maximum 7 days of appropriate IV AB for PVO -

You may not qualify if:

• Previous episodes of PVO within the past 24 months
• Spinal implants inserted prior to current episode of PVO
• Hypersensitivity to an AB intended for use in the patient and no alternative drugs available.
• Oral ABs not possible due to suspicion of reduced absorption
• Oral Abs not possible due to verified or expected bacterial susceptibility or due to expected toxicity of available regimen
• Identification of fungus, mold, TB, Brucella, Actinomyces, Nocardia and P. aeruginosa as etiology
• Severe immunocompromise defined as primary immunodeficiencies, uncontrolled HIV/AIDS, organ transplant recipients, hematological malignancies, patients undergoing biological therapy or chemotherapy and patients treated with prednisolone \>=20 mg daily \>14 days
• Verified or expected reduced compliance (for example iv drug use)
• Pregnancy
• Breastfeeding
• Diagnosed or suspected concomitant or unrelated infections necessitating IV AB therapy beyond 7 days of duration at the time of randomization -

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Osteomyelitis

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Anne-Mette Lebech, MD

CONTACT

+4535458622; anne-mette.lebech@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, associate professor, MD Dsc

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: February 8, 2024
• Study Start: February 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)