Contact information
Type
Scientific
Primary contact
Prof Heikki Peltola
ORCID ID
Contact details
Hospital District of Helsinki and Uusimaa
HUCH Hospital for Children and Adolescents
PO Box 281
Helsinki
00029
Finland
heikki.peltola@hus.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Acronym
OM-SA
Study hypothesis
Current treatment of acute paediatric osteoarticular infections can be considerably shortened and otherwise simplified.
Ethics approval
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)
Study design
Prospective, randomized, noninferiority trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Clindamycin, cephalosporin
Primary outcome measures
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.
Secondary outcome measures
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.
Overall trial start date
01/01/1983
Overall trial end date
01/01/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Children aged between three months to 14 years with bacteriologically proven acute haematogenous osteomyelitis, septic arthritis, or their combination
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
At least 63 in each arm
Participant exclusion criteria
1. Immunocompromized
2. Other underlying diseases
3. Previous osteoarticular infection
Recruitment start date
01/01/1983
Recruitment end date
01/01/2003
Locations
Countries of recruitment
Finland
Trial participating centre
Hospital District of Helsinki and Uusimaa
Helsinki
00029
Finland
Funders
Funder type
Hospital/treatment centre
Funder name
HUCH Hospital for Children and Adolescents, University of Helsinki (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Orion Pharma Ltd (Finland) - decision on funding pending
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
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20842069
Publication citations
-
Results
Peltola H, Pääkkönen M, Kallio P, Kallio MJ, , Short- versus long-term antimicrobial treatment for acute hematogenous osteomyelitis of childhood: prospective, randomized trial on 131 culture-positive cases., Pediatr. Infect. Dis. J., 2010, 29, 12, 1123-1128, doi: 10.1097/INF.0b013e3181f55a89.