Diagnostics, monitoring, and shortening of the treatment of acute haematogenous OsteoMyelitis and Septic Arthritis of childhood
| ISRCTN | ISRCTN38832979 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38832979 |
| Protocol serial number | 1 |
| Sponsor | HUCH Hospital for Children and Adolescents, University of Helsinki (Finland) |
| Funders | HUCH Hospital for Children and Adolescents, University of Helsinki (Finland), Orion Pharma Ltd (Finland) - decision on funding pending |
- Submission date
- 04/01/2007
- Registration date
- 26/02/2007
- Last edited
- 09/03/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Heikki Peltola
Scientific
Scientific
Hospital District of Helsinki and Uusimaa
HUCH Hospital for Children and Adolescents
PO Box 281
Helsinki
00029
Finland
| heikki.peltola@hus.fi |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, randomized, noninferiority trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | OM-SA |
| Study objectives | Current treatment of acute paediatric osteoarticular infections can be considerably shortened and otherwise simplified. |
| Ethics approval(s) | Protocol approved by the Ethical Committees of the participating centres (Central Hospital of Päijät-Häme on March 7, 1983, Jorvi Hospital on May 30, 1983, and Helsinki University Hospital on July 25, 1983) |
| Health condition(s) or problem(s) studied | Acute bacterial osteoarticular infection of children |
| Intervention | Computer-generated list divided patients to receive a long (30 days), or a short (20 days for osteomyelitis, 10 days for septic arthritis) medication. Children being born on an odd day received clindamycin, those born on an even day received first generation cephalosporin. Antimicrobial was given intravenously only for two to four days, the treatment being completed orally. No serum assays were performed. Surgery was kept as minimum, its aim being mainly to obtain an adequate sample for bacteriology. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Clindamycin, cephalosporin |
| Primary outcome measure(s) |
Success rate at least one year post-hospitalization. Failure was defined as a case in which treatment for an osteoarticular infection was reinstituted within one year. |
| Key secondary outcome measure(s) |
All potential defects in the affected bone or joint which, according to the treating paediatrician or orthopaedic surgeon, were likely to leave a residual defect with potential malfunction. |
| Completion date | 01/01/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 14 Years |
| Sex | All |
| Target sample size at registration | 126 |
| Key inclusion criteria | Children aged between three months to 14 years with bacteriologically proven acute haematogenous osteomyelitis, septic arthritis, or their combination |
| Key exclusion criteria | 1. Immunocompromized 2. Other underlying diseases 3. Previous osteoarticular infection |
| Date of first enrolment | 01/01/1983 |
| Date of final enrolment | 01/01/2003 |
Locations
Countries of recruitment
- Finland
Study participating centre
Hospital District of Helsinki and Uusimaa
Helsinki
00029
Finland
00029
Finland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2010 | Yes | No |
