Authorised Therapeutic exploratory (Phase II) acute osteomyelitis of the child

Acute non-severe osteomyelitis in children

EU CTIS ID: 2024-516744-26-00

What this study is testing

Demonstrate the non-inferiority of an outpatient management strategy versus a standard strategy involving hospitalization on complete recovery without relapse at 6 months after an episode of acute osteomyelitis of the 1-5 year old child without criteria of Gravity

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Children ≥ 1 year old 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 scintigraphy or MRI
  • Absence of sepsis (absence of hemodynamic disorders, respiratory disorders, impaired consciousness)
  • And absence of subperiosteal abscess or associated arthritis or deep vein thrombosis
  • And absence of scarlatiniform rash
  • And CRP < 50 mg/ml

You likely can't join if

  • Infections ostéo-articulaires multifocales
  • Sickle cell patients, immunosuppressed
  • Antibiotic treatment in progress or within 48 hours before the emergency room consultation
  • Severe allergy to beta-lactamines
  • Digestive disorders
See the full eligibility criteria
Who can join
  • Children ≥ 1 year old 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 scintigraphy or MRI
  • Absence of sepsis (absence of hemodynamic disorders, respiratory disorders, impaired consciousness)
  • And absence of subperiosteal abscess or associated arthritis or deep vein thrombosis
  • And absence of scarlatiniform rash
  • And CRP < 50 mg/ml
  • And normal initial bone x-ray (or thickening of soft parts).
What rules you out
  • Infections ostéo-articulaires multifocales
  • Sickle cell patients, immunosuppressed
  • Antibiotic treatment in progress or within 48 hours before the emergency room consultation
  • Severe allergy to beta-lactamines
  • Digestive disorders

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.