Pilot trial evaluating the efficacy of different antibiotic treatments for the treatment of prosthetic joint infection in adults who have undergone joint replacement surgery.
John Hunter Hospital
60 participants
May 8, 2017
Interventional
Conditions
Summary
Prosthetic joint infection is a common and expensive problem. Over 100,000 elective joint replacements are performed in Australia each year and this number is growing. Approximately 2% of these will become infected. Prosthetic Joint Infections are a devastating complication of joint replacement, as they are difficult to cure, and treatment generally involves multiple operations and prolonged courses of antibiotics. There is a lack of high quality evidence to inform us of the management of Prosthetic Joint Infections. Acute Prosthetic Joint Infection is most commonly managed with open debridement of the prosthesis, followed by a period of antibiotics, aiming for cure. Despite the overall burden to the health sector and variable outcomes for individuals there is a lack of high quality evidence to inform the management of these infections.The correct duration of intravenous antibiotics is unknown. Following surgical debridement, patients are treated for a variable period with intravenous antibiotics, followed in most cases by a course of oral antibiotics (ranging from none at all to over 12 months, depending on the institution and situation). However, there is a lack of evidence to guide decisions about choice and duration of antibiotic regimens. This uncertainty is reflected in international guidelines: the Infectious Diseases Society of America guidelines recommend “from 2 to 6 weeks” of IV antibiotics (with no guidance or evidence about how to choose this duration). The Musculoskeletal Infection Society guidelines also recommends between 2 and 6 weeks. Both guidelines also recommend 3 to 6 months of oral antibiotic therapy, In adults with acute prosthetic hip or knee joint infection treated with debridement and implant retention is 2 weeks of intravenous antibiotics superior to 6 weeks (with both arms receiving 10 to 12 weeks of oral antibiotic therapy), in terms of an ordinal outcome including clinical cure 12 months after randomisation and antibiotic-related adverse events.
Eligibility
Inclusion Criteria7
- Aged >=18 years
- Prosthetic joint infection of the hip or knee (according to IDSA diagnostic criteria)
- 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)
- Meet IDSA criteria for DAIR (stable implant, no sinus, absence of septic shock).
- One or more identified causative organisms (can be Gram positive, Gram negative or mixed)
- Adequate debridement has been performed or is planned (this means an open as opposed to arthroscopic debridement and exchange of modular components)
- Initial diagnosis is <21 days prior to randomisation.
Exclusion Criteria6
- Additional diagnosis requiring >2 weeks of IV antibiotics in the opinion of the site PI (e.g. Staphylococcus aureus bacteraemia).
- Patient not treated with curative intent.
- Patient unlikely to survive for > 12 months (in the opinion of the site PI).
- Gram positive rifampicin resistant causative organism.
- Gram negative ciprofloxacin resistant causative organism.
- At least one causative organism is Proprionibacterium spp., Gram negative anaerobes, Fungi, Mycobacteria.
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Interventions
At least 14 days of intravenous antibiotics (chosen by the clinician but must be active against the infecting organisms), times from the date of the first adequate debridement. In addition, patients will receive a backbone of oral antibiotics starting 7-14 days after the first adequate debridement and continuing until 12 weeks after the first adequate debridement. For those with one or more Gram positive causative organisms, this will be rifampicin 300-450mg twice daily orally plus either fusidic acid 500mg 3 times a day orally OR ciprofloxacin 750mg twice daily orally OR doxycycline 100mg twice daily orally. The doses given are recommended but not mandated. The dose and choice of companion agent will be determined by the treating clinician(s), based on the organism’s susceptibility profile, and patient tolerability. For those with one or more aerobic Gram negative rods as causative organisms, the oral agent(s) will be ciprofloxacin 750mg twice daily orally alone, or if there is a mixed infection (Gram positive and negative), ciprofloxacin 750mg twice daily orally plus rifampicin 300-450mg twice daily orally.
Locations(5)
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ACTRN12617000127303