Actively Recruiting

Age: 3Months - 17Years
All Genders
NCT06827496

Initial Oral Antibiotics for Bone and Joint Infections in Children

Led by Rigshospitalet, Denmark · Updated on 2025-04-09

100

Participants Needed

1

Research Sites

128 weeks

Total Duration

On this page

Sponsors

R

Rigshospitalet, Denmark

Lead Sponsor

I

Innovation Fund Denmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

Initial oral antibiotic treatment for children and adolescents with uncomplicated bone and joint infections (BJI) has been found non-inferior to initial IV antibiotics in one randomized controlled trial (RCT). The real-world effectiveness of initial oral antibiotics for children and adolescents with BJI is unclear. This nationwide, prospective, multicenter, real-world cohort study aims to compare the effectiveness and safety of initial oral antibiotic treatment for children and adolescents with uncomplicated BJI in a real-world setting with those who received initial oral antibiotics in our RCT.

CONDITIONS

Official Title

Initial Oral Antibiotics for Bone and Joint Infections in Children

Who Can Participate

Age: 3Months - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children and adolescents aged 3 months to 17 years with uncomplicated bone and joint infections
  • Treated with initial oral antibiotics
  • No risk factors for complicated disease such as severe illness, sepsis, rapid symptom progression, pronounced symptoms, severe pain, pronounced soft tissue involvement, foreign material or post-surgical infection
  • No infection with resistant or rare pathogens like Salmonella or MRSA
  • No severe comorbidities including immunodeficiency
  • Patients who received intravenous antibiotic therapy for less than 24 hours before oral antibiotics
Not Eligible

You will not qualify if you...

  • Severe illness or sepsis
  • Rapid symptom progression
  • Pronounced symptoms including severe pain
  • Pronounced soft tissue involvement
  • Presence of foreign material or post-surgical infection
  • Infection with resistant or rare pathogens, for example, Salmonella or MRSA
  • Severe comorbidities such as immunodeficiency
  • Intravenous antibiotic therapy for more than 24 hours before oral antibiotics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Rigshospitalet

Copenhagen Ø, Denmark, 2100

Actively Recruiting

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Research Team

U

Ulrikka Nygaard, Ass Professor, PhD, MD, MPhil

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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