In short
Currently, there is 1 ongoing clinical trial investigating treatment approaches for acute osteomyelitis in children. This trial is taking place in France and compares home-based oral antibiotic treatment with traditional hospital-based intravenous therapy to determine if outpatient management can be as effective as standard hospital care.
Clinical trial locations
Study on Treating Acute Osteomyelitis in Children with Amoxicillin and Cloxacillin Compared to Standard Hospital Care
This clinical trial focuses on comparing two different ways of treating bone infections in young children. The study examines whether treating children at home with oral antibiotics can be just as effective as the traditional approach of keeping them in hospital and giving antibiotics through a vein.
Who can participate:
- Children between 1 and 4 years old
- Children experiencing their first episode of bone infection, with symptoms like difficulty moving that have lasted less than 15 days, often accompanied by fever
- The infection must be confirmed by special imaging tests like bone scintigraphy or MRI
- Children with no signs of severe 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
- CRP levels (a marker measuring inflammation in the body) must be less than 50 mg/ml
- Normal initial bone X-ray, or only showing thickening of soft tissues around the bone
Who cannot participate:
- Children younger than 1 year or older than 5 years
- Children with severe health conditions that make the infection more serious
- Children with other medical conditions that could interfere with the study
- Children who have had a previous episode of the same bone infection
- Children currently participating in another clinical trial
- Children with allergies to the antibiotics used in the study
- Children whose parents or guardians do not agree to participate
What the trial involves:
The main goal of this study is to determine if home treatment with oral antibiotics is as effective as hospital treatment in ensuring complete recovery without the infection returning after six months. Researchers will monitor children for any signs of the infection coming back or any complications during this period.
Children participating in the study will be assigned to one of two treatment approaches. The first approach involves managing the infection at home with antibiotics taken by mouth. The second approach follows the traditional method of hospital care where antibiotics are given directly into the bloodstream through a vein.
Medications being tested:
The study uses several antibiotic medications, including amoxicillin, cloxacillin, clavulanic acid, and cefazolin. Amoxicillin is available in two forms: as a powder mixed with liquid for drinking and as an injection. Cloxacillin and cefazolin are given as injections, while clavulanic acid is taken orally as a powder mixed with liquid. All of these are antibiotics, which are medicines designed to fight bacterial infections.
The study follows children through several phases. After joining and confirming eligibility, children begin treatment with the assigned antibiotic approach. Throughout the study period, regular follow-up appointments are scheduled to monitor the child's progress and ensure the infection is healing properly. The final assessment at six months confirms whether the child has fully recovered without any signs of the infection returning.
Summary
This single ongoing trial represents an important investigation into whether children with bone infections can be safely and effectively treated at home rather than in hospital. The study is being conducted in France and focuses specifically on young children aged 1 to 4 years experiencing their first episode of acute bone infection. By comparing oral antibiotics given at home with intravenous antibiotics administered in hospital, researchers aim to determine if the more convenient home-based approach can achieve the same positive outcomes as traditional hospital care. The trial uses well-established antibiotics including amoxicillin and cloxacillin, with a follow-up period of six months to ensure complete recovery without relapse.
