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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on children with acute osteomyelitis, a bone infection that is not severe. The study aims to compare two different treatment strategies. One strategy involves managing the condition at home with oral antibiotics, while the other involves traditional hospital care with antibiotics given through a vein, known as intravenous therapy. The main goal is to see if the home treatment is just as effective as the hospital treatment in ensuring complete recovery without the infection returning after six months.

The medications being studied include amoxicillin, cloxacillin, clavulanic acid, and cefazolin. Amoxicillin is used in two forms: as a powder for oral suspension and as an injection. Cloxacillin and cefazolin are given as injections, while clavulanic acid is taken orally as a powder mixed with liquid. These medications are all antibiotics, which are drugs used to treat infections caused by bacteria.

During the study, children will receive either the oral antibiotics at home or the intravenous antibiotics in the hospital. The study will monitor the children's recovery over a period of six months to ensure there are no signs of the infection returning or any complications. The study will help determine if treating children with acute osteomyelitis at home is as safe and effective as the traditional hospital treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the child will be assessed to confirm eligibility. This includes ensuring the child is between 1 and 4 years old, has a first episode of acute osteomyelitis, and meets other specific health criteria.

  2. Step 2

    Initial treatment phase

    The child will begin treatment with antibiotics. The specific medications used include amoxicillin and cloxacillin, which are administered orally, and cefazolin, which is given by injection.

    The treatment aims to manage the infection effectively while monitoring the child's response to the medication.

  3. Step 3

    Outpatient management or hospitalization

    The study compares two strategies: outpatient management with oral antibiotics and standard hospitalization with intravenous antibiotics.

    The child will be assigned to one of these strategies to evaluate the effectiveness of each approach in treating acute osteomyelitis.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the child's health will be closely monitored to ensure recovery without complications.

    Regular follow-up appointments will be scheduled to assess the child's progress and adjust treatment if necessary.

  5. Step 5

    Completion of the study

    The primary goal is complete recovery without relapse at 6 months. This means no signs of osteomyelitis and no secondary complications.

    The study will conclude with a final assessment to confirm the child's recovery and evaluate the effectiveness of the treatment strategy used.

Who can join the trial?

7 criteria

  • Children who are at least 1 year old and no older than 4 years old.
  • First episode of **acute osteomyelitis**. This means a sudden 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**, which means no problems with blood flow, breathing, or consciousness.
  • No **subperiosteal abscess**, which is a collection of pus under the outer layer of the bone, no **arthritis** (joint inflammation), and no **deep vein thrombosis** (blood clot in a deep vein).
  • No **scarlatiniform rash**, which is a type of skin rash.
  • **CRP** (C-reactive protein, a marker of inflammation in the body) less than 50 mg/ml.
  • Normal initial bone X-ray, or only thickening of the soft tissues around the bone.

Who cannot join the trial?

8 criteria

  • Children who are not between 1 to 5 years old.
  • Children with severe health conditions that make the disease more serious.
  • Children who have other medical conditions that could interfere with the study.
  • Children who are unable to follow the study procedures for any reason.
  • Children who have had a previous episode of the same condition.
  • Children who are currently participating in another clinical trial.
  • Children who have allergies to the medications used in the study.
  • Children whose parents or guardians do not agree to participate in the study.
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Investigated drugs

  • Oral Antibiotic Therapy

    is used in this trial as part of an outpatient management strategy for treating acute non-severe osteomyelitis in children. This approach involves administering antibiotics by mouth, allowing children to be treated at home rather than in a hospital. The goal is to see if this method is as effective as the traditional hospital-based treatment.

  • Intravenous Antibiotic Therapy

    is the standard treatment used in this trial for children with acute non-severe osteomyelitis. This method involves administering antibiotics directly into the bloodstream through a vein, typically requiring hospitalization. The trial compares this conventional approach to the outpatient strategy to determine if both are equally effective in achieving complete recovery without relapse.

What is already known about the treatment

Amoxicillin – Amoxicillin is an oral antibiotic commonly used to treat bacterial infections, including acute osteomyelitis in children. It is administered in tablet or liquid form, taken by mouth. In medical literature, amoxicillin is well-established as an effective treatment for various bacterial infections. The main therapeutic indication for amoxicillin in this context is to manage acute osteomyelitis in children. At the molecular level, amoxicillin works by inhibiting the synthesis of bacterial cell walls, leading to the destruction of the bacteria. It is classified as a penicillin-type antibiotic.

Investigated diseases

Acute Osteomyelitis in Children – Acute osteomyelitis is an infection in a bone, typically caused by bacteria. In children, it often affects the long bones of the arms and legs. The disease begins suddenly with symptoms such as fever, irritability, and pain in the affected area. Swelling and redness may develop over the infected bone. If untreated, the infection can spread to nearby tissues or joints. The condition requires prompt medical attention to prevent complications.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2024-516744-26-00Protocol codeAPHP 180672Estimated enrolment320 patientsSponsorAssistance Publique Hopitaux De Paris

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