MedTrace Logo

Oral-only Antibiotics for Bone and Joint Infections in Children

NCT04563325 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-04-13

No results posted yet for this study

Summary

A nationwide, multicenter, randomized, non-inferiority trial of children with bone and joint infections. The primary objective is to determine if oral-only antibiotics (experimental arm) is non-inferior to initial intravenous antibiotics followed by oral therapy (control arm). Children will be randomized 1:1. The total treatment duration is identical in both groups. The study is open label with blinding of the primary endpoint assessor.

Conditions

  • Osteomyelitis
  • Septic Arthritis
  • Bone Infection
  • Joint Infection
  • Bone and Joint Infection

Interventions

DRUG

Oral co-amoxiclav or oral dicloxacillin only

High dose oral treatment followed by standard dose oral treatment

DRUG

IV ceftriaxon followed by oral co-amoxiclav or oral dicloxacillin

IV treatment followed by standard dose oral treatment

Sponsors & Collaborators

  • The research foundation of Copenhagen University Hospital, Rigshospitalet

    collaborator UNKNOWN

  • Copenhagen Health Science Partners

    collaborator UNKNOWN

  • Innovation Fund Denmark

    collaborator INDIV

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Allan Bybeck Nielsen, MD · Rigshospitalet, Denmark

  • Ulrikka Nygaard, Ass Prof PhD · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2024-01-01
Completion
2024-08-05

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04563325 on ClinicalTrials.gov