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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR855 |
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Date of registration:
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19/12/2006 |
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Primary sponsor: |
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Public title:
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Efficacy and safety of adjuvant intra-articular corticosteroids in bacterial arthritis.
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Scientific title:
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Efficacy and safety of adjuvant intra-articular corticosteroids in bacterial arthritis. - BACI trial |
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Date of first enrolment:
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9/3/2006 |
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Target sample size:
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50 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=855 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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J.T.
Dissel, van |
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Address:
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Leids Universitair Medisch Centrum
Postbus 9600
, Leids Universitair Medisch Centrum
Afdeling Infectieziekten, C5P
2300 RC
Leiden
The Netherlands |
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Telephone:
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+31715262613 |
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Email:
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j.t.van_dissel@lumc.nl |
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Affiliation:
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Name:
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J.T.
Dissel, van |
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Address:
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Leids Universitair Medisch Centrum
Postbus 9600
, Leids Universitair Medisch Centrum
Afdeling Infectieziekten, C5P
2300 RC
Leiden
The Netherlands |
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Telephone:
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+31715262613 |
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Email:
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j.t.van_dissel@lumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Provision of a written informed consent;
2. Age range 18-85;
3. Bacterial arthritis of at least on of the following native joints:
Wrist, elbow, shoulder, knee or ankle;
4. Positive culture of synovial fluid.
Exclusion criteria: 1. Adequate antibiotic therapy > 72 hours at time of inclusion;
2. Overt signs of osteomyelitis on conventional X-rays;
3. Bacterial arthritis of a prosthetic joint;
4. Surgical drainage of the infected joint before inclusion;
5. Need for surgical drainage at time of inclusion;
6. Bacterial arthritis due to Borrelia burgdorferi or mycobacteria;
7. Allergy for corticosteroids;
8. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude;
9. Clinical judgment by the investigator that the subject should not participate in the study, such as severe co-morbidity.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Bacterial arthritis
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Intervention(s)
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Intraarticular corticosteroid injection or placebo after 72 hours of adequate antibiotic regimen for bacterial artritis.
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Primary Outcome(s)
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The difference of the range of Blantyre Septic Joint Score (BSJS) measurements between placebo en active treatment group at multiple corresponding time points.
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Secondary Outcome(s)
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1. Safety;
2. ESR and CRP;
3. Cartilage Oligomeric Matrix Protein (COMP);
4. Radiological joint damage;
5. Measurement of Health Status with SF-36;
6. Visual Analog Scale (VAS) measurements.
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Source(s) of Monetary Support
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