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Oral vs. Intravenous Antibiotics for Bone and Joint Infection
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January 2022
Oral vs. Intravenous Antibiotics for Bone and Joint Infection
Study Type:Therapy
OE Level Evidence:1
Journal Level of Evidence:1
Oral versus Intravenous Antibiotics for Bone and Joint Infection
N Engl J Med. 2019 Jan 31;380(5): 425-436.Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
1054 patients being treated for bone or joint infection at 26 UK centers were randomized in this non-inferiority trial to receive 6 weeks of oral antibiotic therapy (n=527) or 6 weeks of intravenous antibiotic therapy (n=527). The primary outcome of interest was the rate of definite treatment failure. Secondary outcomes of interest included the rate of treatment discontinuation, catheter complications, diarrhea caused by C.difficile, serious adverse events, length of hospitalization, and patient-reported outcomes (Oxford Hip and Knee Scores [OHS; OKS]; EuroQual-5Dimension scores [EQ-5D]). Outcomes were assessed at 6 weeks, 4 months, and 1 year follow-up. Oral antibiotics were found to be non-inferior to intravenous antibiotics with regards to the risk of definitive treatment failure. The incidence of early discontinuation of treatment and catheter complications, and length of hospitalization were significantly higher in the intravenous group, however, no differences in the incidence of diarrhea or serious adverse events were observed between the two groups. EQ-5D scores and OHS scores were not significantly different between groups at 4 months and 1 year post-treatment, however, OKS scores were better in the oral group at both time points.
Publication Funding Details
Funding
Government
Funding Details
Supported by the National Institute for Health Research Health
Technology Assessment program (project number 11/36/29), the NIHR Imperial College Biomedical Research Centre (to Dr. Cooke), and the NIHR Oxford Biomedical Research Centre (to Drs. Walker, M. Scarborough, and Bejon).
Disclosures
Consultant, Other, Grants
Why was this study needed now?
Patients with bone and joint infection require prolonged antibiotic treatment, which is frequently delivered intravenously. However, the use of intravenous antibiotics has been associated with additional complications and higher costs vs. oral antibiotics. Therefore, it is of interest to determine whether oral antibiotics can provide an non-inferior management of bone and joint infection.
What was the principal research question?
In patients with acute or chronic bone/joint infection, is oral antibiotic therapy non-inferior to intravenous antibiotic therapy with respect to treatment success, within 1 year post-randomization?
What were the important study characteristics?
Population
1054
Total Sample Size
Patients aged 18 years or older who would have ordinarily been treated with 6 weeks of intravenous therapy for an acute or chronic bone or joint infection.
Intervention
527
Antibiotics (Oral)
Median age 60. 67.9% male. Patients received 6 weeks of oral antibiotic therapy as soon as possible (within 7 days of surgery, or if the infection was being managed without surgery, within 7 days after the start of antibiotic treatment). Antibiotics were selected by the infection specialist, and follow-up therapy beyond the 6 weeks was permitted and not governed by the trial protocol.
Comparison
527
Antibiotics (Intravenous)
Median age 61. 60.7% male. Patients received 6 weeks of intravenous antibiotic therapy as soon as possible (within 7 days of surgery, or if the infection was being managed without surgery, within 7 days after the start of antibiotic treatment). Antibiotics were selected by the infection specialist, and follow-up therapy beyond the 6 weeks was permitted and not governed by the trial protocol.
Outcomes
Incidence of serious adverse event
Serious Adverse Events
Lower = Better
Methods
RCT
Randomized Controlled Trial
Multi-Centered
Locations: United Kingdom
Time
1 Years
Outcomes: Serious Adverse Events
What were the important findings?
Oral antibiotics were found to be non-inferior to intravenous antibiotics with regards to the risk of definitive treatment failure. The incidence of early discontinuation of treatment and catheter complications, as well as length of hospitalization, were significantly higher in the intravenous group, however, no difference in the incidence of C.difficile-associated diarrhea was observed between the two groups. EQ-5D scores and OHS scores were not significantly different between groups at 4 months and 1 year post-treatment, however, OKS scores were better in the oral group at both time points.
Significantly Better
No Difference
Significantly Better
Antibiotics (Intravenous)
Antibiotics (Oral)
Serious Adverse Events
Risk of Bias
Proportion of Events (Lower = Better)
Incidence of serious adverse event
1 Years
Risk of Bias
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Healthcare Professionals: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Overall risk of bias
High Risk of Bias
Some Concern
Low Risk of Bias
Risk of Bias
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Healthcare Professionals: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Overall risk of bias
What should I remember most and how will this affect the care of my patients?
The results of this study suggest that oral antibiotics are non-inferior to intravenous antibiotics for the management of bone and joint infection, as measured by treatment failure. Moreover, oral antibiotics are associated with a shorter length of stay and fewer complications compared to intravenous treatment. This study was limited by the open label design and potential differences in follow-on treatment. This study challenges the widely accepted standard use of intravenous antibiotics for bone/joint infection.
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