Condition category
Musculoskeletal Diseases
Date applied
21/12/2007
Date assigned
05/02/2008
Last edited
05/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Javier Ariza Cardenal

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Oral rifampin-cotrimoxazole combination may be as useful as the standard intravenous cloxacillin therapy against chronic osteomyelitis by Staphylococcus aureus.

Ethics approval

Ethics approval received from the Investigation Committee of Hospital de Bellvitge in January 1991.

Study design

Single centre interventional randomised, active controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Cloxacillin, rifampin-cotrimoxazole, trimethoprim

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/04/1991

Overall trial end date

31/12/1996

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Exploratory study. Fifty patients included

Participant exclusion criteria

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

Recruitment start date

01/04/1991

Recruitment end date

31/12/1996

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital de Bellvitge
Barcelona
08907
Spain

Sponsor information

Organisation

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

Sponsor details

c/o Dr. Javier Ariza Cardenal
Hospital de Bellvitge
Feixa Llarga s/n
L'Hospitalet de Llobregat
Barcelona
08907
Spain

Sponsor type

Hospital/treatment centre

Website

http://www.idibell.es

Funders

Funder type

Hospital/treatment centre

Funder name

Hospital de Bellvitge (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes