Osteomyelitis Trials in Disease

Study on Treating Acute Osteomyelitis in Children with Amoxicillin and Cloxacillin Compared to Standard Hospital Care

This trial is being conducted in France and focuses on children with a first episode of acute bone infection that is not severe. The study compares two different ways of treating this condition: managing it at home with oral antibiotics versus traditional hospital care with antibiotics given through a vein.

Who can participate:

• Children between 1 and 4 years old
• First-time episode of acute bone infection, suspected based on symptoms like difficulty moving for less than 15 days, often with fever, and confirmed by special imaging tests like bone scintigraphy or MRI
• No signs of sepsis (serious blood infection affecting blood flow, breathing, or consciousness)
• No collection of pus under the bone's outer layer, no joint inflammation, and no blood clots in deep veins
• No specific type of skin rash called scarlatiniform rash
• CRP (a marker showing inflammation in the body) less than 50 mg/ml
• Normal initial bone X-ray, or only showing thickening of the soft tissues around the bone

Who cannot participate:

• Children outside the 1 to 5 year age range
• Children with severe health conditions that make the disease more serious
• Children with other medical conditions that could interfere with the study
• Children unable to follow study procedures
• Children who have had a previous episode of the same condition
• Children currently participating in another clinical trial
• Children with allergies to the study medications
• Children whose parents or guardians do not agree to participate

What the trial involves:

The study aims to determine if treating children at home with oral antibiotics is as safe and effective as traditional hospital treatment with intravenous antibiotics. The main goal is to see if children achieve complete recovery without the infection returning after six months.

Children participating in the study will receive one of two treatment strategies. The first strategy involves oral antibiotics taken at home, while the second involves intravenous antibiotics given in the hospital. The medications being studied include amoxicillin, cloxacillin, clavulanic acid, and cefazolin. These are all antibiotics used to fight bacterial infections.

Throughout the study, children's health will be closely monitored with regular follow-up appointments to assess their progress and adjust treatment if necessary. The study will track recovery over six months to ensure there are no signs of the infection returning or any complications.

Investigational drugs:

The trial tests two approaches to antibiotic therapy. Oral antibiotic therapy allows children to take their medication by mouth at home, avoiding hospitalization. Intravenous antibiotic therapy is the standard hospital-based treatment where antibiotics are delivered directly into the bloodstream through a vein. The study compares these two methods to see if they are equally effective in achieving complete recovery.