Outpatient management of non-severe osteomyelitis in children using oral antibiotics

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: a Randomized Open-label Non-inferiority Study With Bayesian and Medical-economic Analyses.

This study tests if giving oral antibiotics at home can help young children with mild osteomyelitis recover just as well as being treated in the hospital with IV antibiotics.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 320 (estimated)
• Ages: 1 Year to 4 Years
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Paris)
• Trial ID: NCT04554108 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of an outpatient management strategy for children aged 1 to 4 years with acute non-severe osteomyelitis, comparing it to the standard approach that requires hospitalization and intravenous antibiotics. The study aims to demonstrate that starting oral antibiotic treatment in an outpatient setting is non-inferior to traditional hospitalization in terms of complete recovery without relapse after six months. The trial includes children with specific clinical criteria and excludes those with severe symptoms or complications. The primary endpoint is the absence of clinical signs of osteomyelitis and related complications at the six-month follow-up.

Who should consider this trial

Good fit: Ideal candidates are children aged 1 to 4 years experiencing their first episode of acute osteomyelitis without severe symptoms.

Not a fit: Patients with multifocal infections, severe allergies, or those who are immunocompromised may not benefit from this outpatient management strategy.

Why it matters

Potential benefit: If successful, this approach could reduce hospital stays and associated healthcare costs for children with non-severe osteomyelitis.

How similar studies have performed: Other studies have explored outpatient management for similar conditions, showing promising results, but this specific approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

Child ≥ 1 year and 4 years old ;

* First episode of acute osteomyelitis suspected on clinical grounds (acute functional impotence (\<15 days) most often associated with fever) and confirmed in the first days of treatment by bone scan or MRI.
* Absence of severity criteria :

  * Fever \< 39°C
  * AND absence of sepsis (absence of hemodynamic disorders, respiratory disorders, consciousness disorders)
  * AND absence of periosteal abscess or associated arthritis or deep vein thrombosis
  * AND absence of scarlatiniform rash (no gap of healthy skin)
  * AND CRP \< 50 mg/ml
  * AND normal initial bone radiograph (or simple soft tissue thickening).

Exclusion Criteria:

* Multifocal osteoarticular infections
* Sickle cell or immunocompromised patients
* Antibiotic treatment in progress or within 48 hours prior to the emergency room visit
* History of severe beta-lactam allergy (anaphylactic shock, angioedema)
* Digestive problems (vomiting or diarrhea)
* Refusal of parents to participate
* Parents (children) not affiliated to social security or without CMU
* Parents who do not speak French
* Participation in another intervention research protocol

Where this trial is running

Paris

• Trousseau Hospital — Paris, France (Recruiting)

Study contacts

• Principal investigator: Mathie LORROT, MD PhD — Aphp
• Study coordinator: Mathie LORROT, MD PhD

Conditions Osteomyelitis