SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis

NCT06250023 · tracked via the Priya Life Science Denmark tracker

Sponsor

Copenhagen University Hospital, Rigshospitalet

Phase

Observational

Started

2024-02-01

Last updated

2024-03-22

Condition(s) studied

Osteomyelitis; Vertebra

Investigational drug(s) / intervention(s)

Early shift til oral antibiotic treatment for osteomyelitis

Early shift til oral antibiotic treatment for osteomyelitis: 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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Age ≥18 years 2. 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) 3. The physician responsible for the patient decides to treat the patient for PVO 4. At time of randomization CRP has decreased to \< 75% of peak value or to \< 20 mg/l 5. At the time of randomization patient has received maximum 7 days of appropriate IV AB for PVO - Exclusion Criteria: 1. Previous episodes of PVO within the past 24 months 2. Spinal implants inserted prior to current episode of PVO 3. Hypersensitivity to an AB intended for use in the patient and no alternative drugs available. 4. Oral ABs not possible due to suspicion of reduced absorption 5. Oral Abs not possible due to verified or expected bacterial susceptibility or due to expected toxicity of available regimen 6. Identification of fungus, mold, TB, Brucella, Actinomyces, Nocardia and P. aeruginosa as etiology 7. 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 8. Verified or expected reduced compliance (for example iv drug use) 9. Pregnancy 10. Breastfeeding 11. 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. 12. Patients not capable of providing informed consent at time of screening for inclusion 13. Diagnosed or suspected concomitant or unrelated infections necessitating IV AB therapy beyond 7 days of duration at the time of randomization -

Primary outcome measure(s)

Primary outcome — Six months after completion of oral antibiotic treatment
All-cause mortality
Primary outcome — Six months after completion of oral antibiotic treatment
Unplanned surgical intervention in relation to the spine
Primary outcome — Six months after completion of oral antibiotic treatment
Relapse of bacteremia with primary pathogen
Primary outcome — 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)
Primary outcome — 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

Trial sites (1)

Facility	City	Region	Status
Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark	Copenhagen	Denmark	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06250023 on ClinicalTrials.gov ↗ ← All trials in Denmark