Trial Outcomes & Findings for Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J) (NCT NCT00974493)
NCT ID: NCT00974493
Last Updated: 2020-06-05
Results Overview
Number of participants with definite failure of infection treatment defined by microbiological, histological and clinical criteria and assessed by an independent blinded endpoint committee
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1054 participants
Primary outcome timeframe
1 year
Results posted on
2020-06-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
527
|
527
|
|
Overall Study
COMPLETED
|
509
|
506
|
|
Overall Study
NOT COMPLETED
|
18
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Oral Antibiotics
n=527 Participants
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.
|
Intravenous Antibiotics
n=527 Participants
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.
|
Total
n=1054 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
60 years
n=527 Participants
|
61 years
n=527 Participants
|
60 years
n=1054 Participants
|
|
Sex: Female, Male
Female
|
169 Participants
n=527 Participants
|
207 Participants
n=527 Participants
|
376 Participants
n=1054 Participants
|
|
Sex: Female, Male
Male
|
358 Participants
n=527 Participants
|
320 Participants
n=527 Participants
|
678 Participants
n=1054 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
527 participants
n=527 Participants
|
527 participants
n=527 Participants
|
1054 participants
n=1054 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Modified ITT (excluding participants without available endpoint data)
Number of participants with definite failure of infection treatment defined by microbiological, histological and clinical criteria and assessed by an independent blinded endpoint committee
Outcome measures
| Measure |
Oral Antibiotics
n=509 Participants
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.
|
Intravenous Antibiotics
n=506 Participants
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.
|
|---|---|---|
|
The Frequency of Definite Failure of Infection Treatment.
|
67 Participants
|
74 Participants
|
Adverse Events
Oral Antibiotics
Serious events: 138 serious events
Other events: 80 other events
Deaths: 6 deaths
Intravenous Antibiotics
Serious events: 146 serious events
Other events: 86 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Oral Antibiotics
n=527 participants at risk
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.
|
Intravenous Antibiotics
n=527 participants at risk
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.
|
|---|---|---|
|
General disorders
All
|
26.2%
138/527
|
27.7%
146/527
|
|
Infections and infestations
C difficile
|
0.96%
5/523
|
1.7%
9/523
|
|
Injury, poisoning and procedural complications
Line complication
|
0.96%
5/523
|
9.4%
49/523
|
|
Nervous system disorders
Neurological
|
1.9%
10/527
|
0.76%
4/527
|
|
Cardiac disorders
Cardiovascular
|
5.5%
29/527
|
4.9%
26/527
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
4.0%
21/527
|
2.7%
14/527
|
|
Gastrointestinal disorders
Gastrointestinal
|
2.5%
13/527
|
4.0%
21/527
|
|
Renal and urinary disorders
Renal
|
2.3%
12/527
|
2.1%
11/527
|
|
Endocrine disorders
Diabetic
|
1.9%
10/527
|
1.3%
7/527
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplastic
|
1.1%
6/527
|
0.76%
4/527
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
4.0%
21/527
|
3.2%
17/527
|
|
Skin and subcutaneous tissue disorders
Skin and soft tissue unrelated to original surgical site
|
1.3%
7/527
|
1.9%
10/527
|
Other adverse events
| Measure |
Oral Antibiotics
n=527 participants at risk
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.
|
Intravenous Antibiotics
n=527 participants at risk
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.
|
|---|---|---|
|
General disorders
Related to the operative site
|
13.1%
69/527
|
8.7%
46/527
|
|
General disorders
Antibiotic related
|
2.8%
15/527
|
5.7%
30/527
|
|
General disorders
Frailty related
|
0.95%
5/527
|
1.9%
10/527
|
Additional Information
Matthew Scarborough
Oxford University Hospitals NHS Trust
Phone: 07872436461
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place