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The study will compare the outcomes of treating bone and joint infections with 6 weeks of intravenous antibiotics with 6 weeks of oral antibiotic treatment. The trial is of antibiotic "strategy" rather than of individual antibiotics. The study will be open label, but the primary outcome will be proven failure of infection treatment, determined by pre-established objective criteria for treatment failure. The null hypothesis tested is that there will be no difference in treatment failure rates.
A long course of antibiotic therapy given by a "drip" (i.e. intravenous) is recommended treatment for many serious bacterial infections. It is costly and inconvenient for the patient to remain hospitalised for therapy, so outpatient antibiotic therapy (OPAT) programmes have been established in many countries to deliver intravenous antibiotics safely and conveniently. The majority of patients referred to OPAT programmes have bone and joint infections. However, there is no clear evidence that bone and joint infection really require long courses of intravenous antibiotics rather than oral antibiotics.
We will compare the outcome of treatment with intravenous versus oral antibiotic therapy for patients with bone and joint infection. The choice of antibiotic is complex, and antibiotics that are suitable oral choices are often not suitable intravenous choices and vice versa. Subjects will therefore be randomized to an oral or intravenous "strategy," rather than to individual antibiotics. Outcomes will be determined by pre-established objective criteria for treatment failure.
We have conducted a pilot study in one centre (Oxford), recruiting approximately 200 patients, and are now expanding to include multi-centre recruitment in the UK, aiming to recruit 1050 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral antibiotics | Active Comparator |
| |
| Intravenous antibiotics | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotics | Drug | The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics. Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| The Frequency of Definite Failure of Infection Treatment. | Number of participants with definite failure of infection treatment defined by microbiological, histological and clinical criteria and assessed by an independent blinded endpoint committee | 1 year |
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Inclusion Criteria:
Is willing and able to give informed consent for participation in the study. Has a bone and joint infection one of the following categories;
Has had at least 48 hours, but not more than 7 days, of IV antibiotic therapy already given after definitive surgical management.
Has a clinical diagnosis of bacterial infection (caused by any organism excepting mycobacteria).
Is clinically stable in the opinion of the study clinicians, has no further interventions to treat acute infection required or planned.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Bejon, PhD | Oxford Radcliffe Hospitals Trust | Principal Investigator |
| Matthew Scarborough, MB BS | Oxford University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuffield Orthopaedic Centre | Oxford | Oxfordshire | OX3 7LD | United Kingdom | ||
| Oxford Radcliffe Hospitals Trust |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Antibiotics | Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics. Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines. |
| FG001 | Intravenous Antibiotics | Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics. Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Antibiotics | Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics. Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Frequency of Definite Failure of Infection Treatment. | Number of participants with definite failure of infection treatment defined by microbiological, histological and clinical criteria and assessed by an independent blinded endpoint committee | Modified ITT (excluding participants without available endpoint data) | Posted | Count of Participants | Participants | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Antibiotics | Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics. Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All | General disorders | Non-systematic Assessment | Adverse Event data were not available for 8 participants in relation to C difficile and Line Complication. For events collected by non-systematic methods, data are reported with reference to organ system rather than specific adverse event term |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Related to the operative site | General disorders | Non-systematic Assessment | Includes directed specialist care for symptom control, wound management, mobility, skin and soft tissue infection, dislocation or recurrent primary endpoint |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Scarborough | Oxford University Hospitals NHS Trust | 07872436461 | matthew.scarborough@ouh.nhs.uk |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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|
|
| Oxford |
| Oxfordshire |
| OX3 9DU |
| United Kingdom |
| BG001 | Intravenous Antibiotics | Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics. Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Intravenous Antibiotics |
Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics. Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines. |
|
|
| 6 |
| 527 |
| 138 |
| 527 |
| 80 |
| 527 |
| EG001 | Intravenous Antibiotics | Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics. Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines. | 17 | 527 | 146 | 527 | 86 | 527 |
|
| C difficile | Infections and infestations | Systematic Assessment | C difficile was reported as a defined secondary outcome. No data available from 4 participants in each arm |
|
| Line complication | Injury, poisoning and procedural complications | Systematic Assessment | Line complications were reported as a defined secondary outcome. No data available from 4 participants in each arm |
|
| Neurological | Nervous system disorders | Non-systematic Assessment |
|
| Cardiovascular | Cardiac disorders | Non-systematic Assessment |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment |
|
| Renal | Renal and urinary disorders | Non-systematic Assessment |
|
| Diabetic | Endocrine disorders | Non-systematic Assessment |
|
| Neoplastic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Skin and soft tissue unrelated to original surgical site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
|
| Antibiotic related | General disorders | Non-systematic Assessment | Antibiotic related events represented here were attributed by the responsible infection specialist to antibiotic therapy (as opposed to unrelated co-morbidities). |
|
| Frailty related | General disorders | Non-systematic Assessment | Frailty related events included slips, trips or falls in the elderly or readmission as a result of inability to cope at home |
|
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