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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Intercommunal Creteil	Creteil	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Fondation Lenval Nice	Nice	France
Centre Hospitalier Sud Francilien	Corbeil Essonnes	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital NOVO	Pontoise	France
Grand Hopital De L Est Francilien	Meaux	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Cqlzep Hcboupjixrj Smb Ecydetxblhpsgdygpgkfdax	Etampes	France
Cmrhwq Hlhjdgsxyav Rvmnwusy Ukltuwlwcwlkc Dg Tqphl	Tours	France
Ivowgttv dt Cslbtpmjpkkw Hbsgjiwgoel Umnwrohkccyde dq Sucqh Eisdnrg (oxfhiar	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	31.05.2021

Trial locations

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.

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 ID:

2024-516744-26-00

Protocol code:

APHP 180672

NCT ID:

NCT04554108

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

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