A study comparing the administration of short and long antibiotic treatment in patients with bone infections

Phase 1

• Conditions: Orthopaedic infections, including chronic osteomyelitis and prosthetic joint infection) needing prolonged courses of antibiotics (6 weeks or more)and also surgical treatment; MedDRA version: 20.0Level: PTClassification code 10031252Term: OsteomyelitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: HLTClassification code 10005941Term: Bone and joint infections (excl arthritis)System Organ Class: 100000004859; MedDRA version: 20.0Level: HLTClassification code 10005940Term: Bone and joint infectionsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 21.1Level: PTClassification code 10076011Term: Application site joint infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 21.1Level: PTClassification code 10076118Term: Medical device site joint infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: PTClassification code 10060803Term: Diabetic foot infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2022-000602-10-ES
• Lead Sponsor: Oxford University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-18
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1)Provision of informed consent
2)Aged 18 years or over
3)Presenting with an orthopaedic infection, defined by one or more of the following criteria:
a) localised pain, OR
b) localised erythema, OR
c) temperature = 38.0ºC, OR
d) a discharging sinus or wound
4)Undergoing surgical treatment for the infection
5)Locally administered antibiotics in a HTA-approved product or in a carrier CE marked for antibiotic delivery
6)Has received <= 7 days of systemic antimicrobial therapy after surgery
7)Would ordinarily be managed with a prolonged course (>= 4 weeks) of systemic antibiotic(s)
8)Specimens for microbiological analysis taken at index surgery
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Surgical exclusion criteria
1) The index operation was not a definitive procedure with the aim of eradicating infection:
a) Primary closure has not been achieved, or
b) Re-look surgery is planned
2) The index operation involved implant retention (e.g. DAIR)
Microbiological exclusion criteria
3) 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
4) Other infection necessitating additional systemic antibiotic treatment beyond 7 days after surgery, such as Staphylococcus aureus bacteraemia, psoas abscess, discitis or bacterial endocarditis.
5) If the patient is in a clinical trial involving an Investigational Medicinal Product (IMP) related to infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified