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.

NCT04554108 | Unknown

• 2 other identifiers: APHP1806722019-003522-25
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of bone and joint infections (BJI) in children (osteomyelitis, septic arthritis and spondylodiscitis) is 22 per 100,000 children in France. Every year, 3,000 children are hospitalized for BJI, 46% of whom are hospitalized for osteomyelitis. The clinical pictures of BJI are varied: some are severe from the outset; others are non-severe, such as BJIs in Kingella kingae, which are most common in children between the ages of 6 months and 5 years. Currently, the management of children's BJI, regardless of their severity, involves initial hospitalization to start intravenous antibiotic therapy. This non-inferiority trial evaluates, in children with acute osteomyelitis with no severity criteria, less invasive outpatient management with an oral antibiotic treatment given at the outset compared to standard management. Main objective : Demonstrate the non-inferiority of an ambulatory management strategy versus a standard strategy involving hospitalization on complete recovery without relapse at 6 months after an episode of acute osteomyelitis in children aged 1-4 years without severity criteria. Primary endpoint: Complete cure 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, periosteal abscess) before the end of antibiotic therapy AND the absence of relapse or rehospitalization for osteomyelitis related to the initial infection. This criterion will be assessed blindly by an adjudication committee. Randomized controlled trial of non inferiority, with active control, in open multi-center. The control or experimental arm allocation (1:1 ratio) will be open-label of the physician, patient and parents. This is a PROBE study: The evaluation of the main judgment criterion will be carried out blindly by an adjudication committee.

Conditions

Osteomyelitis

Outcome Measures

Primary Outcomes (1)

• Complete recovery without relapse at 6 months

  Complete recovery without relapse defined by the absence of clinical signs of osteomyelitis (absence of pain, fever, swelling \& heat of any limb, biological inflammatory signs, relapse or hospitalisation AND the absence of secondary septic complications (septic arthritis, sub-periosteal abscess)

  6 months

Study Arms (2)

Intravenous antibiotic treatment

ACTIVE COMPARATOR

Intravenous antibiotic treatment started during an initial hospitalization of 3 days, with continuation of oral antibiotic therapy at home for a total duration of antibiotic therapy of 3 weeks

Other: therapeutic strategy

oral antibiotic treatment

EXPERIMENTAL

Oral antibiotic treatment started in hospital then continued at home for a total duration of 3 weeks of antibiotic therapy

Other: therapeutic strategy

Interventions

therapeutic strategy OTHER

Outpatient management strategy of acute non-severe osteomyelitis in children with oral antibiotic therapy compared to a standard strategy with conventional hospitalization and intravenous antibiotic therapy

Intravenous antibiotic treatment; oral antibiotic treatment

Eligibility Criteria

• Age: 1 Year - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Trousseau Hospital

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Osteomyelitis

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Mathie LORROT, MD PhD

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathie LORROT, MD PhD

CONTACT

+331 44 73 62 20; mathie.lorrot@aphp.fr

Franck FITOUSSI, MD PhD

CONTACT

+331 44 73 68 51; franck.fitoussi@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial of non inferiority, with active control, in open multicenter.

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 18, 2020
• Study Start: May 31, 2021
• Primary Completion: November 30, 2024
• Study Completion: May 31, 2025
• Last Updated: October 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)