Clinical trial • Phase II • Infectious Disease
CEF A ZOLIN for Acute osteomyelitis
Phase II trial of CEF A ZOLIN for Acute osteomyelitis.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Acute osteomyelitis
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 15-10-2024
- First CTIS Authorization Date
- 15-11-2024
Trial design
Randomised, open-label, standard strategy with conventional hospitalization and intravenous antibiotic therapy (hospitalization + iv antibiotics) — comparator described as hospitalization with iv antibiotic therapy; specific drug choice/dose/schedule not specified in the available data.-controlled Phase II trial across 34 sites in France.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Standard strategy with conventional hospitalization and intravenous antibiotic therapy (hospitalization + IV antibiotics) — comparator described as hospitalization with IV antibiotic therapy; specific drug choice/dose/schedule not specified in the available data.
- Target Sample Size
- 320
- Trial Duration For Participant
- 180
Eligibility
Recruits 320 paediatric patients.
- Vulnerable Population
- Children aged 1–4 years are included; isVulnerablePopulationSelected = true. Specific consent/assent procedures are not detailed in the provided data; a Subject Information and Informed Consent Form document is listed (L1_SIS and ICF-AP) but its contents (who provides consent, assent requirements, languages) are not provided.
Inclusion criteria
- {"criterion_text":"- Children ≥ 1 year old and ≤4 years old;"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Absence of sepsis (absence of hemodynamic disorders, respiratory disorders, impaired consciousness)"}
- {"criterion_text":"- And absence of subperiosteal abscess or associated arthritis or deep vein thrombosis"}
- {"criterion_text":"- And absence of scarlatiniform rash"}
- {"criterion_text":"- And CRP < 50 mg/ml"}
- {"criterion_text":"- And normal initial bone x-ray (or thickening of soft parts)."}
Exclusion criteria
- {"criterion_text":"- Infections ostéo-articulaires multifocales"}
- {"criterion_text":"- Sickle cell patients, immunosuppressed"}
- {"criterion_text":"- Antibiotic treatment in progress or within 48 hours before the emergency room consultation"}
- {"criterion_text":"- Severe allergy to beta-lactamines"}
- {"criterion_text":"- Digestive disorders"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Complete recovery without relapse at 6 months defined by the absence of clinical signs of osteomyelitis at 6 months AND the absence of secondary septic complications (septic arthritis, perioste abscess) before the end of antibiotic therapy AND the absence of relapse or rehospitalization for osteomyelitis in relation to the initial infection.","definition_or_measurement_approach":"Defined as absence of clinical signs of osteomyelitis at 6 months, absence of secondary septic complications (septic arthritis, periosteal abscess) before end of antibiotic therapy, and absence of relapse or rehospitalization for osteomyelitis related to the initial infection."}
Recruitment
- Planned Sample Size
- 320
- Recruitment Window Months
- 54
- Consent Approach
- Not specified in the available data. A Subject Information and Informed Consent Form document is listed (L1_SIS and ICF-AP), but the content (who provides consent, age-specific documents, languages, assent) is not provided. Given the population (children 1–4 years) consent would be expected from parent/legal guardian, but this is not explicitly detailed in the provided record.
Geography
- Total Number Of Sites
- 34
- Total Number Of Participants
- 320
France
- Earliest CTIS Part Ii Submission Date
- 07-11-2024
- Latest Decision Or Authorization Date
- 09-04-2025
- Processing Time Days
- 153
- Number Of Sites
- 34
- Number Of Participants
- 320
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pédiatrie
- Principal Investigator Name
- Romain BASMACI
- Principal Investigator Email
- romain.basmaci@aphp.fr
- Contact Person Name
- Romain BASMACI
- Contact Person Email
- romain.basmaci@aphp.fr
- Site Name
- Hopital NOVO
- Department Name
- Pédiatrie
- Principal Investigator Name
- Jean-Louis Ceolin
- Principal Investigator Email
- jean-louis.ceolin@ght-novo.fr
- Contact Person Name
- Jean-Louis Ceolin
- Contact Person Email
- jean-louis.ceolin@ght-novo.fr
- Site Name
- Grand Hopital De L Est Francilien
- Department Name
- Pédiatrie
- Principal Investigator Name
- Placide AGBO
- Principal Investigator Email
- kagbokpati@ghef.fr
- Contact Person Name
- Placide AGBO
- Contact Person Email
- kagbokpati@ghef.fr
- Site Name
- Centre Hospitalier De Versailles
- Department Name
- Pédiatrie
- Principal Investigator Name
- Véronique HENTGEN
- Principal Investigator Email
- vhentgen@ch-versailles.fr
- Contact Person Name
- Véronique HENTGEN
- Contact Person Email
- vhentgen@ch-versailles.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Orthopédie
- Principal Investigator Name
- Faustine MONGET
- Principal Investigator Email
- faustine.mon@gmail.com
- Contact Person Name
- Faustine MONGET
- Contact Person Email
- faustine.mon@gmail.com
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Orthopédie
- Principal Investigator Name
- Franck FITOUSSI
- Principal Investigator Email
- franck.fitoussi@aphp.fr
- Contact Person Name
- Franck FITOUSSI
- Contact Person Email
- franck.fitoussi@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Pédiatrie
- Principal Investigator Name
- François DUBOS
- Principal Investigator Email
- francois.dubos@chru-lille.fr
- Contact Person Name
- François DUBOS
- Contact Person Email
- francois.dubos@chru-lille.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Pédiatrie
- Principal Investigator Name
- Sandra BISCARDI
- Principal Investigator Email
- sandra.biscardi@chicreteil.fr
- Contact Person Name
- Sandra BISCARDI
- Contact Person Email
- sandra.biscardi@chicreteil.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Orthopédie
- Principal Investigator Name
- Jean-Charles Auregan
- Principal Investigator Email
- jean-charles.auregan@aphp.fr
- Contact Person Name
- Jean-Charles Auregan
- Contact Person Email
- jean-charles.auregan@aphp.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Orthopédie
- Principal Investigator Name
- Thierry Odent
- Principal Investigator Email
- L.AGOSTINI@chu-tours.fr
- Contact Person Name
- Thierry Odent
- Contact Person Email
- L.AGOSTINI@chu-tours.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Orthopédie
- Principal Investigator Name
- Antoine CHALOPIN
- Principal Investigator Email
- Antoine.CHALOPIN@chu-nantes.fr
- Contact Person Name
- Antoine CHALOPIN
- Contact Person Email
- Antoine.CHALOPIN@chu-nantes.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Orthopédie
- Principal Investigator Name
- Jamil Amhis
- Principal Investigator Email
- Jamil.Amhis@chicreteil.fr
- Contact Person Name
- Jamil Amhis
- Contact Person Email
- Jamil.Amhis@chicreteil.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pédiatrie
- Principal Investigator Name
- Vincent GAJDOS
- Principal Investigator Email
- vincent.gajdos@aphp.fr
- Contact Person Name
- Vincent GAJDOS
- Contact Person Email
- vincent.gajdos@aphp.fr
- Site Name
- Fondation Lenval Nice
- Department Name
- Orthopédie
- Principal Investigator Name
- Virginie RAMPAL
- Principal Investigator Email
- rocher-rampal.v@pediatrie-chulenval-nice.fr
- Contact Person Name
- Virginie RAMPAL
- Contact Person Email
- rocher-rampal.v@pediatrie-chulenval-nice.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pédiatrie
- Principal Investigator Name
- Mathie LORROT
- Principal Investigator Email
- mathie.lorrot@aphp.fr
- Contact Person Name
- Mathie LORROT
- Contact Person Email
- mathie.lorrot@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Pédiatrie
- Principal Investigator Name
- Camille BREHIN
- Principal Investigator Email
- brehin.c@chu-toulouse.fr
- Contact Person Name
- Camille BREHIN
- Contact Person Email
- brehin.c@chu-toulouse.fr
- Site Name
- Grand Hopital De L Est Francilien
- Department Name
- Pédiatrie
- Principal Investigator Name
- Caroline MASSEROT
- Principal Investigator Email
- cmasserot@ghef.fr
- Contact Person Name
- Caroline MASSEROT
- Contact Person Email
- cmasserot@ghef.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Urgences
- Principal Investigator Name
- Laetitia Agostini
- Principal Investigator Email
- L.AGOSTINI@chu-tours.fr
- Contact Person Name
- Laetitia Agostini
- Contact Person Email
- L.AGOSTINI@chu-tours.fr
- Site Name
- Fondation Lenval Nice
- Department Name
- Pédiatrie
- Principal Investigator Name
- Hervé HAAS
- Principal Investigator Email
- herve.haas@free.fr
- Contact Person Name
- Hervé HAAS
- Contact Person Email
- herve.haas@free.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Orthopédie
- Principal Investigator Name
- Antoine JOSSE
- Principal Investigator Email
- antoine.josse@chu-lyon.fr
- Contact Person Name
- Antoine JOSSE
- Contact Person Email
- antoine.josse@chu-lyon.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Pédiatrie
- Principal Investigator Name
- Yves GILLET
- Principal Investigator Email
- yves.gillet@chu-lyon.fr
- Contact Person Name
- Yves GILLET
- Contact Person Email
- yves.gillet@chu-lyon.fr
- Site Name
- Centre Hospitalier Sud Francilien
- Department Name
- Rhumatologie Pédiatrique
- Principal Investigator Name
- Glory DINGULU
- Principal Investigator Email
- glory.dingulu@chsf.fr
- Contact Person Name
- Glory DINGULU
- Contact Person Email
- glory.dingulu@chsf.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Urgences
- Principal Investigator Name
- Aymeric Cantais
- Principal Investigator Email
- Aymeric.Cantais@chu-st-etienne.fr
- Contact Person Name
- Aymeric Cantais
- Contact Person Email
- Aymeric.Cantais@chu-st-etienne.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Urgences
- Principal Investigator Name
- Marion FAVIER
- Principal Investigator Email
- marion.favier@chu-bordeaux.fr
- Contact Person Name
- Marion FAVIER
- Contact Person Email
- marion.favier@chu-bordeaux.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Rhumatologie Pédiatrique
- Principal Investigator Name
- Caroline GALEOTTI
- Principal Investigator Email
- caroline.galeotti@aphp.fr
- Contact Person Name
- Caroline GALEOTTI
- Contact Person Email
- caroline.galeotti@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pédiatrie
- Principal Investigator Name
- Melusine Kiener
- Principal Investigator Email
- melusine.kiener@aphp.fr
- Contact Person Name
- Melusine Kiener
- Contact Person Email
- melusine.kiener@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Orthopédie
- Principal Investigator Name
- Elie HADDAD
- Principal Investigator Email
- Elie.HADDAD@chu-st-etienne.fr
- Contact Person Name
- Elie HADDAD
- Contact Person Email
- Elie.Haddad@chu-st-etienne.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pédiatrie
- Principal Investigator Name
- Grégoire BENOIST
- Principal Investigator Email
- gregoire.benoist@aphp.fr
- Contact Person Name
- Grégoire BENOIST
- Contact Person Email
- gregoire.benoist@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Pédiatrie
- Principal Investigator Name
- Eric JEZIORSKI
- Principal Investigator Email
- e-jeziorski@chu-montpellier.fr
- Contact Person Name
- Eric JEZIORSKI
- Contact Person Email
- e-jeziorski@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Pédiatrie
- Principal Investigator Name
- Elise LAUNAY
- Principal Investigator Email
- elise.launay@chu-nantes.fr
- Contact Person Name
- Elise LAUNAY
- Contact Person Email
- elise.launay@chu-nantes.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Pédiatrie
- Principal Investigator Name
- Zoha Maakaroun Vermesse
- Principal Investigator Email
- Z.MAAKAROUN-VERMESSE@chu-tours.fr
- Contact Person Name
- Zoha Maakaroun Vermesse
- Contact Person Email
- Z.MAAKAROUN-VERMESSE@chu-tours.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Orthopédie
- Principal Investigator Name
- Jérôme COTTALORDA
- Principal Investigator Email
- j-cottalorda@chu-montpellier.fr
- Contact Person Name
- Jérôme COTTALORDA
- Contact Person Email
- j-cottalorda@chu-montpellier.fr
- Site Name
- Centre Hospitalier Sud Essonne-Dourdan-Etampes
- Department Name
- Pédiatrie
- Principal Investigator Name
- Cédric TAHIRI
- Principal Investigator Email
- ctahiri@ch-sudessonne.fr
- Contact Person Name
- Cédric TAHIRI
- Contact Person Email
- ctahiri@ch-sudessonne.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pédiatrie
- Principal Investigator Name
- Elsa Foucaud
- Principal Investigator Email
- elsa.foucaud@aphp.fr
- Contact Person Name
- Elsa Foucaud
- Contact Person Email
- elsa.foucaud@aphp.fr
Sponsor
Primary sponsor
- Full Name
- Assistance Publique Hopitaux De Paris
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- CEFAZOLIN
- Active Substance
- CEF A ZOLIN
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Maximum Dose
- 150 mg/kg
- Investigational Product Name
- CLOXACILLIN
- Active Substance
- CLOXACILLIN
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Maximum Dose
- 150 mg/kg
- Investigational Product Name
- CLAVULANIC ACID
- Active Substance
- CLAVULANIC ACID
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 10 mg/kg
- Investigational Product Name
- AMOXICILLIN (oral suspension)
- Active Substance
- AMOXICILLIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 80 mg/kg
- Investigational Product Name
- AMOXICILLIN (injection)
- Active Substance
- AMOXICILLIN
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Maximum Dose
- 150 mg/kg
- Combination Treatment
- Yes
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