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Oral rifampin-cotrimoxazole combination versus intravenous cloxacillin in chronic staphylococcal osteomyelitis: a long-term follow-up trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27058472
Enrollment
50
Registered
2008-02-05
Start date
1991-04-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Non-axial chronic osteomyelitis due to Staphylococcus aureus Musculoskeletal Diseases Chronic osteomyelitis

Interventions

After surgery and identification of Staphylococcus aureus upon surgical samples, randomisation of patients for antibiotic therapy: Group A: intravenous cloxacillin (2 g every four hours [q4h]) for 6

Sponsors

Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients (greater than 18 years old) of any gender with chronic osteomyelitis by Staphylococcus aureus treated with surgery.

Exclusion criteria

Exclusion criteria: 1. Prosthetic joint infection 2. Methicillin resistant Staphylococcus aureus 3. Allergy to protocol antibiotics 4. Strain resistance to cotrimoxazole or rifampin

Design outcomes

Primary

MeasureTime frame
Treatment failure rate, defined as the number of cases with clinical relapse (appearance or recurrence of local inflammatory signs or sinus tract drainage, with or without microbiological confirmation) during follow-up.

Secondary

MeasureTime frame
1. Treatment tolerability and compliance (number of patients who did not fulfil protocol treatment and reason), from patient inclusion to the end of antibiotic therapy (8 weeks) 2. Length of hospital stay (days) for each treatment schedule; defined as hospitalisation during the diagnosis and treatment of the episode

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026