Short or Long Antibiotic Regimes in Orthopaedics
A legfontosabb adatok
- Ki végzi
- Oxford University Hospitals NHS Trust
- Hol
- Egyesült Királyság, Németország, Portugália és Spanyolország23 helyszín, 4 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Befejeződött
- Résztvevők
- 500 fő vett részt
- Kezdés
- 2019. febr. 21.
- Befejezés
- 2025. jan. 31.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Shorter Systemic Antibiotics
- Standard treatment
- A regiszteradat frissítve
- 2025. április 3.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 14 feltétel megnézéseKevesebb
Ki vehet részt
- Provision of informed consent
- Aged 18 years or over
- Presenting with an orthopaedic infection, defined by one or more of the following criteria:; localised pain, OR; localised erythema, OR; temperature ≥ 38.0 C, OR; a discharging sinus or wound
- Undergoing surgical treatment for the infection
- Locally administered antibiotic(s) at the site of orthopaedic infection
- Has received <= 7 days of systemic antimicrobial therapy after surgery
- Would ordinarily be managed with a prolonged course (>= 4 weeks) of systemic antibiotic(s)
- Specimens for microbiological analysis taken at index surgery
Ki nem vehet részt
- Surgical exclusion criteria
- The index operation involved implant retention (e.g. DAIR); Microbiological exclusion criteria
- The index operation was not a definitive procedure with the aim of eradicating infection:; Primary closure has not been achieved, or; Re-look surgery is planned
- Any identified micro-organisms from operative specimens from the site of incident infection are fully resistant to the local antibiotic(s) administered at the site of infection; Medical exclusion criteria
- Other infection necessitating additional systemic antibiotic treatment beyond 7 days after surgery, such as Staphylococcus aureus bacteraemia, psoas abscess, discitis or bacterial endocarditis
- If the patient is in a clinical trial involving an Investigational Medicinal Product (IMP) related to infection
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
4 országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
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?
A teljes eredeti leírásKevesebb
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.
A vizsgálat 2 csoportja
- Shorter Systemic AntibioticsA vizsgált kezelés
Participants will receive local antibiotic therapy at the time of surgery, followed by one week or less of systemic antibiotic therapy, for bone and joint infection.
- Long Systemic AntibioticsMár használt kezelés, összehasonlításként
Participants will receive local antibiotic therapy at the time of surgery, followed by four weeks or more of systemic antibiotic therapy (standard treatment recommended by international guidelines), for bone and joint infection.
Kezelés: Standard treatment
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): A Randomised Open Label Multi-Centre Clinical Trial
- A regiszteradat frissítve
- 2025. április 3.