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Efficacy and safety of adjuvant intra-articular corticosteroids in bacterial arthritis.

Efficacy and safety of adjuvant intra-articular corticosteroids in bacterial arthritis.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21879
Enrollment
50
Registered
2006-12-19
Start date
2006-03-09
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intraarticular corticosteroid injection or placebo after 72 hours of adequate antibiotic regimen for bacterial artritis.

Sponsors

Academisch Medisch Centrum, Universiteit van Amsterdam, Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The difference of the range of Blantyre Septic Joint Score (BSJS) measurements between placebo en active treatment group at multiple corresponding time points.

Secondary

MeasureTime frame
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.

Contacts

Public ContactJ.T. Dissel, van

Leids Universitair Medisch Centrum Postbus 9600

j.t.van_dissel@lumc.nl+31715262613

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)