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

ISRCTN	ISRCTN27058472
DOI	https://doi.org/10.1186/ISRCTN27058472
Protocol serial number	N/A
Sponsor	Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)
Funder	Hospital de Bellvitge (Spain)

Submission date: 21/12/2007
Registration date: 05/02/2008
Last edited: 05/02/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Javier Ariza Cardenal
Scientific

Hospital de Bellvitge
Feixa Llarga s/n
L'Hospitalet de Llobregat
Barcelona
08907
Spain

Study information

Primary study design	Interventional
Study design	Single centre interventional randomised, active controlled study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Oral rifampin-cotrimoxazole combination may be as useful as the standard intravenous cloxacillin therapy against chronic osteomyelitis by Staphylococcus aureus.
Ethics approval(s)	Ethics approval received from the Investigation Committee of Hospital de Bellvitge in January 1991.
Health condition(s) or problem(s) studied	Non-axial chronic osteomyelitis due to Staphylococcus aureus
Intervention	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 weeks followed by oral cloxacillin (500 mg every six hours [q6h]) for 2 weeks Group B: oral rifampin-cotrimoxazol combination for 8 weeks (rifampin 600 mg every 24 hours [q24h] plus 7 - 8 mg/kg per day of trimethoprim component, equivalent to three simple strength cotrimoxazole capsules, every 12 hours [q12h]) The total duration of the protocol treatment was 8 weeks for both groups (6 intravenous [iv] and 2 oral [po] in the cloxacillin group and 8 po in the rifampin-cotrimoxazole group). The duration of the follow-up is from the end of antibiotic therapy until 2007 (a median of 10 years).
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Cloxacillin, rifampin-cotrimoxazole, trimethoprim
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/12/1996

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key inclusion criteria	Adult patients (greater than 18 years old) of any gender with chronic osteomyelitis by Staphylococcus aureus treated with surgery.
Key exclusion criteria	1. Prosthetic joint infection 2. Methicillin resistant Staphylococcus aureus 3. Allergy to protocol antibiotics 4. Strain resistance to cotrimoxazole or rifampin
Date of first enrolment	01/04/1991
Date of final enrolment	31/12/1996

Locations

Countries of recruitment

Spain

Study participating centre

Hospital de Bellvitge

Barcelona
08907
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan