NCT03806166: SOLARIO

Short or Long Antibiotic Regimes in Orthopaedics

Completed NA Last updated 3 April 2025

What this trial tests

NA trial testing Shorter Systemic Antibiotics in Osteomyelitis in 500 participants. Completed in 31 January 2025.

Timeline

21 February 2019

Primary endpoint
4 December 2024

31 January 2025

Quick facts

Lead sponsor	Oxford University Hospitals NHS Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	500
Start date	21 February 2019
Primary completion	4 December 2024
Estimated completion	31 January 2025
Sites	23 locations across Portugal, United Kingdom, Germany, Spain

Drugs / interventions tested

• Shorter Systemic Antibiotics
• Standard treatment

Conditions studied

• Osteomyelitis — all drugs for Osteomyelitis →
• Prosthetic Joint Infection — all drugs for Prosthetic Joint Infection →
• Diabetic Foot — all drugs for Diabetic Foot →

Sponsor

Oxford University Hospitals NHS Trust

Who can join

18 and older, any sex, with Osteomyelitis or Prosthetic Joint Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Research question: If adults with bone or joint infection have local antibiotic therapy, can they do without prolonged treatment with antibiotics by mouth (oral) or injection?

Adults with bone or joint infections are usually given long courses of oral antibiotics or into a vein (intravenous) following surgery. It is also safe to give antibiotics directly into the bone or joint at the time of surgery: this is called local antibiotic therapy. This study investigates whether using local antibiotic therapy would allow shorter courses of oral or intravenous antibiotics, in order to limit antibiotic resistance, side effects and cost.

This study compares short against long courses of oral or intravenous antibiotics for adults who have been given appropriate local antibiotic therapy to treat bone or joint infection. Patients who can take part will be randomly divided into two groups within 7 days of surgery. One group will stop oral or intravenous antibiotics, while the other group will continue for 4 weeks or more (standard treatment).

Adults with bone and joint infections who have already had surgery and local antibiotic therapy will be invited. Patients will not take part if they need intravenous antibiotics for another reason, or if their infection is caused by bacteria resistant to the antibiotic(s) used in their local antibiotic therapy.

Main measurement: how many patients' infections return within 12 months after surgery. This will be decided by a group of doctors who do not know what treatment the patient received.

Other important measurements: serious adverse events; side-effects; quality of life; cost of treatment.

Patients will be asked questions at their usual clinic visits, and will be given a questionnaire at the start of treatment and 1 year later.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): a randomised controlled open-label non-inferiority trial of duration of systemic antibiotics in adults with orthopaedic infection treated operatively with local antibiotic therapy.
   Dudareva M, Kümin M, Vach W, Kaier K, et al · · 2019 · cited 41× · PMID 31815653 · DOI 10.1186/s13063-019-3832-3
2. Surgical site application of antibiotics: A potential game changer for fracture-related infection care and antibiotic stewardship.
   Bangash F, Muddassir M, Barlow G. · · 2023 · cited 1× · PMID 38009080 · DOI 10.1016/j.jor.2023.10.032