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 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Prof Javier Ariza Cardenal
Scientific
Scientific
Hospital de Bellvitge
Feixa Llarga s/n
L'Hospitalet de Llobregat
Barcelona
08907
Spain
Study information
| Study design | Single centre interventional randomised, active controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | 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. |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cloxacillin, rifampin-cotrimoxazole, trimethoprim |
| Primary outcome measure | 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 study start date | 01/04/1991 |
| Overall study end date | 31/12/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Exploratory study. Fifty patients included |
| Participant inclusion criteria | Adult patients (greater than 18 years old) of any gender with chronic osteomyelitis by Staphylococcus aureus treated with surgery. |
| 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
Study participating centre
Hospital de Bellvitge
Barcelona
08907
Spain
08907
Spain
Sponsor information
Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr. Javier Ariza Cardenal
Hospital de Bellvitge
Feixa Llarga s/n
L'Hospitalet de Llobregat
Barcelona
08907
Spain
| Website | http://www.idibell.es |
|---|---|
"ROR" |
https://ror.org/0008xqs48 |
Funders
Funder type
Hospital/treatment centre
Hospital de Bellvitge (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
