Pilot trial evaluating the efficacy of different antibiotic treatments for the treatment of prosthetic joint infection in adults who have undergone joint replacement surgery.

Phase 4

Completed

• Conditions: Prosthetic joint infection; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12617000127303
• Lead Sponsor: John Hunter Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-24
• Study Completion: 2020-12-15
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) Aged >=18 years
2) Prosthetic joint infection of the hip or knee (according to IDSA diagnostic criteria)
3) Acute infection (either a. Diagnosis <4 weeks from date of implantation of prosthesis OR b. Suspected acute haematogenous infection with <3 weeks from symptom onset to diagnosis)
4) Meet IDSA criteria for DAIR (stable implant, no sinus, absence of septic shock).
5) One or more identified causative organisms (can be Gram positive, Gram negative or mixed)
6) Adequate debridement has been performed or is planned (this means an open as opposed to arthroscopic debridement and exchange of modular components)
7) Initial diagnosis is <21 days prior to randomisation.

Exclusion Criteria

1) Additional diagnosis requiring >2 weeks of IV antibiotics in the opinion of the site PI (e.g. Staphylococcus aureus bacteraemia).
2) Patient not treated with curative intent.
3) Patient unlikely to survive for > 12 months (in the opinion of the site PI).
4) Gram positive rifampicin resistant causative organism.
5) Gram negative ciprofloxacin resistant causative organism.
6) At least one causative organism is Proprionibacterium spp., Gram negative anaerobes, Fungi, Mycobacteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seven level ordinal outcome including clinical cure 12 months after randomisation and antibiotic-related adverse events (the categories are as follows:<br>1. Clinical cure with no antibiotic (AB)-related complications<br>2. Clinical cure with minor AB-related complications<br>3. Clinical cure with major AB-related complications <br>4. Lack of clinical cure, with no AB-related complications<br>5. Lack of clinical cure, with minor AB-related complications<br>6. Lack of clinical cure, with major AB-related complications.<br>7. Death from any cause.)<br>Clinical cure will be defined as no clinical or microbiological evidence of infection; original prosthesis still present; and no use of ongoing antibiotic therapy for the index joint. <br> [At 12 months post randomisation]