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Acute non-severe osteomyelitis in children - Outpatient management strategy with oral antibiotic therapy compared to a standard strategy with conventional hospitalization and intravenous antibiotic therapy: randomized open-label non-inferiority study with Bayesian and medico-economic analyses.

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516744-26-00
Acronym
APHP 180672
Enrollment
320
Registered
2024-11-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute osteomyelitis of the child

Brief summary

Complete recovery without relapse at 6 months defined by the absence of clinical signs of osteomyelitis at 6 months AND the absence of secondary septic complications (septic arthritis, perioste abscess) before the end of antibiotic therapy AND the absence of relapse or rehospitalization for osteomyelitis in relation to the initial infection.

Interventions

DRUGCEFAZOLIN
DRUGAMOXICILLIN

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Complete recovery without relapse at 6 months defined by the absence of clinical signs of osteomyelitis at 6 months AND the absence of secondary septic complications (septic arthritis, perioste abscess) before the end of antibiotic therapy AND the absence of relapse or rehospitalization for osteomyelitis in relation to the initial infection.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026