Switch precoce a terapia orale con amoxicillina (combinazione di farmaci) rispetto a 14 giorni in pazienti con osteomielite vertebrale

Enrollment and baseline Assessment

After signing the informed consent, you undergo a baseline Assessment that includes medical history, physical Examination, blood tests and imaging of the spine.

The results are used to confirm the diagnosis of pyogenic vertebral osteomyelitis and to determine eligibility for the study.

Start of intravenous antibiotic therapy

You receive an intravenous antibiotic infusion each day according to the study protocol.

The specific drug, dose and infusion Schedule are selected by the Treating Physician and follow standard dosing guidelines.

Early switch to oral antibiotics (Group a) or standard switch (Group B)

If you are assigned to the early‑switch Group, the intravenous antibiotic is stopped after 7 days and you begin an oral antibiotic regimen.

If you are assigned to the standard‑switch Group, the intravenous antibiotic continues for 14 days before the switch to oral therapy.

The oral antibiotics may include any of the following agents, taken at the doses indicated:

• amoxicillin 6 g per day, divided in multiple doses
• cefadroxil 4000 mg per day, divided in multiple doses
• amoxicillin/clavulanic acid 4000 mg per day (as film‑coated tablets)
• doxycycline 300 mg per day, divided in two doses
• rifampicin 1200 mg per day, divided in two doses
• phenoxymethylpenicillin 8 million IU per day, divided in three doses
• ciprofloxacin 1500 mg per day, divided in two doses
• metronidazole 2000 mg per day, divided in three doses
• moxifloxacin 400 mg per day, single dose
• clindamycin 1800 mg per day, divided in three doses
• cefalexin 4000 mg per day, divided in four doses
• flucloxacillin 12 g per day, divided in four doses
• levofloxacin 1000 mg per day, divided in two doses
• linezolid 1200 mg per day, divided in two doses
• co‑trimoxazole (sulfamethoxazole 640 mg + trimethoprim) 640 mg per day, divided in two doses

The oral therapy is continued until the total duration of antibiotic treatment defined by the protocol is completed.

Regular follow‑up during oral therapy

You attend scheduled Clinic visits to assess clinical response, side effects and laboratory parameters.

Blood tests are repeated as required, and any adverse events are recorded.

Completion of antibiotic therapy

The oral antibiotic course is stopped after the predefined treatment period.

The exact length of therapy depends on individual clinical response and protocol specifications.

Post‑treatment observation period

After stopping antibiotics, you are followed for 24 weeks without further antibiotic exposure.

During this period, you may have additional visits to monitor for relapse or complications.

Final Assessment of primary endpoint

At 24 weeks after the end of therapy, a Comprehensive Evaluation is performed to determine whether any of the following occurred:

• all‑cause mortality
• unplanned spine‑related surgery for vertebral osteomyelitis
• relapse of bacteraemia with the original pathogen
• relapse of infection at the spine or iliopsoas muscle with the original pathogen
• renewed intravenous antibiotic therapy for more than 7 days for treatment of vertebral osteomyelitis

This Evaluation constitutes the primary endpoint of the trial.