Condition category
Infections and Infestations
Date applied
04/01/2007
Date assigned
26/02/2007
Last edited
09/03/2011
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 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

Sponsor information

Organisation

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

Sponsor details

PO Box 281
Helsinki
00029
Finland

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes