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NCT Number: NCT06250023

SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis

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.

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Key information

Conditions

Osteomyelitis; Vertebra Bone Diseases Bone Diseases, Infectious Infections Musculoskeletal Diseases Osteomyelitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Anne-Mette C Lebech, MD

CONTACT

[email protected]

+4535458622

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 -

Exclusion criteria

  • 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
  • Women of childbearing potential, who at the time of inclusion are not using and/or who will not use an effective anticonception method during the treatment period.
  • Patients not capable of providing informed consent at time of screening for inclusion
  • Diagnosed or suspected concomitant or unrelated infections necessitating IV AB therapy beyond 7 days of duration at the time of randomization -

Treatment and study plan

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.

Primary outcomes

  1. Primary outcome

    Time frame: Six months after completion of oral antibiotic treatment

    All-cause mortality

  2. Primary outcome

    Time frame: Six months after completion of oral antibiotic treatment

    Unplanned surgical intervention in relation to the spine

  3. Primary outcome

    Time frame: Six months after completion of oral antibiotic treatment

    Relapse of bacteremia with primary pathogen

  4. Primary outcome

    Time frame: Six months after completion of oral antibiotic treatment

    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)

  5. Primary outcome

    Time frame: Six months after completion of oral antibiotic treatment

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

Secondary outcomes

  1. Secondary outcome 1

    Time frame: Six months after completion of oral antibiotic treatment

    Occurrence of each component of the composite primary endpoint from the time of shift to oral AB treatment to six months after completion of oral AB treatment.

  2. Secondary outcome 2

    Time frame: Six months after completion of oral antibiotic treatment

    Median duration of hospital admission(s) from the time of shift to oral AB treatment to six months after completion of oral AB treatment (Admission defined as overnight stay at the department)

  3. Secondary outcome 3

    Time frame: Six months after completion of oral antibiotic treatment

    Number of readmissions from the time of shift to oral AB treatment to six months after completion of oral AB treatment

  4. Secondary outcome 4

    Time frame: Six months after completion of oral antibiotic treatment

    Proportion of patients receiving additional oral AB therapy beyond the duration defined in the protocol

  5. Secondary outcome 5

    Time frame: Six months after completion of oral antibiotic treatment

    Proportion of patients having early termination of allocated treatment strategy due to adverse events, patient preference, or any other reason

  6. Secondary outcome 6

    Time frame: Six months after completion of oral antibiotic treatment

    Proportion of patients experiencing complications associated with IV treatment (e.g., catheter infections, phlebitis, bleeding, venous thrombosis, need for replacement of catheter) from the time of initiation of IV treatment for PVO to six months after completion of oral AB treatment

  7. Secondary outcome 7

    Time frame: Six months after completion of oral antibiotic treatment

    Proportion of patients experiencing severe adverse events from ABs from the time of initiation of IV treatment for PVO to six months after completion of oral AB treatment

  8. Secondary outcome 8

    Time frame: Six months after completion of oral antibiotic treatment

    Proportion of patients experiencing adverse events from ABs from the time of initiation of IV treatment for PVO to six months after completion of oral AB treatment

  9. Secondary outcome 9

    Time frame: Six months after completion of oral antibiotic treatment

    Proportion of patients diagnosed with Clostridioides difficile associated diarrhea from the time of initiation of IV treatment for PVO to six months after completion of oral AB treatment

  10. Secondary outcome 10

    Time frame: Six months after completion of oral antibiotic treatment

    Quality of life scores (EQ-5D) at the following timepoints: Randomization, 1 week after the end of AB therapy, 1 month after the end of AB therapy, 6 months after the end of oral AB therapy, and 12 months after the end of oral AB therapy

  11. Secondary outcome 11

    Time frame: Six months after completion of oral antibiotic treatment

    Resource allocation/cost assessment determined by a combination of EQ5D, DALYs, Days of hospital admission and antibiotic prescribing costs

  12. Secondary outcome 12

    Time frame: Six months after completion of oral antibiotic treatment

    CRP, WBC, alkaline phosphatase and procalcitonin at randomization as well as CRP, WBC, alkaline phosphatase weekly during treatment and at week 4, 12 and 24 after completion of oral AB treatment.

  13. Secondary outcome 13

    Time frame: Six months after completion of oral antibiotic treatment

    Presence of microbial cell-free DNA in blood samples at the time of randomization and 6 months after the end of oral AB therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Mette Lebech, MD

CONTACT

[email protected]

+4535458622

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Early Shift to Oral Antibiotic Treatment for Pyogenic Vertebral Osteomyelitis (SAVE) - a Open Label Non-inferiority Nation-wide Study

Acronym: SAVE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 8, 2024
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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