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Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J) (OVIVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00974493
Recruitment Status : Completed
First Posted : September 10, 2009
Results First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Matthew Scarborough, Oxford University Hospitals NHS Trust

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Bone Infection
Joint Infection
Intervention Drug: Antibiotics
Enrollment 1054
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oral Antibiotics Intravenous Antibiotics
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 527 527
Completed 509 506
Not Completed 18 21
Arm/Group Title Oral Antibiotics Intravenous Antibiotics Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 527 527 1054
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 527 participants 527 participants 1054 participants
60
(18 to 91)
61
(18 to 92)
60
(18 to 92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 527 participants 527 participants 1054 participants
Female
169
  32.1%
207
  39.3%
376
  35.7%
Male
358
  67.9%
320
  60.7%
678
  64.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 527 participants 527 participants 1054 participants
527 527 1054
1.Primary Outcome
Title The Frequency of Definite Failure of Infection Treatment.
Hide Description Number of participants with definite failure of infection treatment defined by microbiological, histological and clinical criteria and assessed by an independent blinded endpoint committee
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT (excluding participants without available endpoint data)
Arm/Group Title Oral Antibiotics Intravenous Antibiotics
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 509 506
Measure Type: Count of Participants
Unit of Measure: Participants
67
  13.2%
74
  14.6%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral Antibiotics Intravenous Antibiotics
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Oral Antibiotics Intravenous Antibiotics
Affected / at Risk (%) Affected / at Risk (%)
Total   6/527 (1.14%)   17/527 (3.23%) 
Hide Serious Adverse Events
Oral Antibiotics Intravenous Antibiotics
Affected / at Risk (%) Affected / at Risk (%)
Total   138/527 (26.19%)   146/527 (27.70%) 
Cardiac disorders     
Cardiovascular *  29/527 (5.50%)  26/527 (4.93%) 
Endocrine disorders     
Diabetic *  10/527 (1.90%)  7/527 (1.33%) 
Gastrointestinal disorders     
Gastrointestinal *  13/527 (2.47%)  21/527 (3.98%) 
General disorders     
All * [1]  138/527 (26.19%)  146/527 (27.70%) 
Infections and infestations     
C difficile  [2]  5/523 (0.96%)  9/523 (1.72%) 
Injury, poisoning and procedural complications     
Line complication  [3]  5/523 (0.96%)  49/523 (9.37%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal *  21/527 (3.98%)  17/527 (3.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplastic *  6/527 (1.14%)  4/527 (0.76%) 
Nervous system disorders     
Neurological *  10/527 (1.90%)  4/527 (0.76%) 
Renal and urinary disorders     
Renal *  12/527 (2.28%)  11/527 (2.09%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory *  21/527 (3.98%)  14/527 (2.66%) 
Skin and subcutaneous tissue disorders     
Skin and soft tissue unrelated to original surgical site *  7/527 (1.33%)  10/527 (1.90%) 
*
Indicates events were collected by non-systematic assessment
[1]
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
Indicates events were collected by systematic assessment
[2]
C difficile was reported as a defined secondary outcome. No data available from 4 participants in each arm
[3]
Line complications were reported as a defined secondary outcome. No data available from 4 participants in each arm
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oral Antibiotics Intravenous Antibiotics
Affected / at Risk (%) Affected / at Risk (%)
Total   80/527 (15.18%)   86/527 (16.32%) 
General disorders     
Related to the operative site * [1]  69/527 (13.09%)  46/527 (8.73%) 
Antibiotic related * [2]  15/527 (2.85%)  30/527 (5.69%) 
Frailty related * [3]  5/527 (0.95%)  10/527 (1.90%) 
*
Indicates events were collected by non-systematic assessment
[1]
Includes directed specialist care for symptom control, wound management, mobility, skin and soft tissue infection, dislocation or recurrent primary endpoint
[2]
Antibiotic related events represented here were attributed by the responsible infection specialist to antibiotic therapy (as opposed to unrelated co-morbidities).
[3]
Frailty related events included slips, trips or falls in the elderly or readmission as a result of inability to cope at home
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Matthew Scarborough
Organization: Oxford University Hospitals NHS Trust
Phone: 07872436461
EMail: matthew.scarborough@ouh.nhs.uk
Layout table for additonal information
Responsible Party: Matthew Scarborough, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00974493    
Other Study ID Numbers: OVIVA
First Submitted: September 4, 2009
First Posted: September 10, 2009
Results First Submitted: February 24, 2020
Results First Posted: June 5, 2020
Last Update Posted: June 5, 2020