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
Secondary identifying numbers 1
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

Hospital District of Helsinki and Uusimaa
HUCH Hospital for Children and Adolescents
PO Box 281
Helsinki
00029
Finland

Email heikki.peltola@hus.fi

Study information

Study designProspective, randomized, noninferiority trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymOM-SA
Study objectivesCurrent 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) studiedAcute bacterial osteoarticular infection of children
InterventionComputer-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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Clindamycin, cephalosporin
Primary outcome measureSuccess 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 measuresAll 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 study start date01/01/1983
Completion date01/01/2003

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit3 Months
Upper age limit14 Years
SexBoth
Target number of participantsAt least 63 in each arm
Key inclusion criteriaChildren aged between three months to 14 years with bacteriologically proven acute haematogenous osteomyelitis, septic arthritis, or their combination
Key exclusion criteria1. Immunocompromized
2. Other underlying diseases
3. Previous osteoarticular infection
Date of first enrolment01/01/1983
Date of final enrolment01/01/2003

Locations

Countries of recruitment

  • Finland

Study participating centre

Hospital District of Helsinki and Uusimaa
Helsinki
00029
Finland

Sponsor information

HUCH Hospital for Children and Adolescents, University of Helsinki (Finland)
Hospital/treatment centre

PO Box 281
Helsinki
00029
Finland

ROR logo "ROR" https://ror.org/02e8hzf44

Funders

Funder type

Hospital/treatment centre

HUCH Hospital for Children and Adolescents, University of Helsinki (Finland)

No information available

Orion Pharma Ltd (Finland) - decision on funding pending

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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