Last updated: March 20, 2024
Sponsor: Rigshospitalet, Denmark
Overall Status: Active - Recruiting
Phase
N/A
Condition
Osteomyelitis
Treatment
Early shift til oral antibiotic treatment for osteomyelitis
Clinical Study ID
NCT06250023
2023-507617-96-01
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥18 years
- Diagnosed with PVO by a physician based on clinical symptoms and findings consistentwith 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 ABfor PVO -
Exclusion
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 drugsavailable.
- Oral ABs not possible due to suspicion of reduced absorption
- Oral Abs not possible due to verified or expected bacterial susceptibility or due toexpected toxicity of available regimen
- Identification of fungus, mold, TB, Brucella, Actinomyces, Nocardia and P. aeruginosaas etiology
- Severe immunocompromise defined as primary immunodeficiencies, uncontrolled HIV/AIDS,organ transplant recipients, hematological malignancies, patients undergoingbiological therapy or chemotherapy and patients treated with prednisolone >=20 mgdaily >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 whowill 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 therapybeyond 7 days of duration at the time of randomization -
Study Design
Total Participants: 530
Treatment Group(s): 1
Primary Treatment: Early shift til oral antibiotic treatment for osteomyelitis
Phase:
Study Start date:
February 01, 2024
Estimated Completion Date:
October 31, 2026
Connect with a study center
Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark
Copenhagen, 2100
DenmarkActive - Recruiting
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