Shortening IV Antibiotic Treatment for Spine Infections

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

This study is testing if giving people with spine infections a week of IV antibiotics instead of six weeks can still help them get better.

Quick facts

• Study type: Observational
• Enrollment: 530 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rigshospitalet, Denmark (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Copenhagen)
• Trial ID: NCT06250023 on ClinicalTrials.gov

What this trial studies

This study investigates whether reducing the duration of intravenous antibiotic treatment to one week for patients with pyogenic vertebral osteomyelitis (PVO) is as effective as the current guideline of six weeks. It focuses on both uncomplicated and complicated cases of PVO, aiming to determine if a shorter IV treatment followed by oral antibiotics can achieve similar outcomes. Patients will be monitored based on clinical symptoms and diagnostic imaging results to assess the effectiveness of this approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with pyogenic vertebral osteomyelitis who have shown a decrease in inflammatory markers.

Not a fit: Patients with previous episodes of vertebral osteomyelitis, spinal implants, or specific bacterial infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a more efficient treatment protocol for vertebral osteomyelitis, reducing hospital stays and improving patient quality of life.

How similar studies have performed: While this approach is novel in the context of vertebral osteomyelitis, similar studies in other infections have shown promising results with shorter antibiotic regimens.

Eligibility criteria

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 -

Where this trial is running

Copenhagen

• Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark — Copenhagen, Denmark (Recruiting)

Study contacts

• Study coordinator: Anne-Mette Lebech, MD

Conditions Osteomyelitis; Vertebra