Informations générales (source: ClinicalTrials.gov)
Acute Non-severe Osteomyelitis in Children - Outpatient Management Strategy With Oral Antibiotic Therapy Compared to a Standard Strategy With Conventional Hospitalization and Intravenous Antibiotic Therapy: a Randomized Open-label Non-inferiority Study With Bayesian and Medical-economic Analyses. (POOMA)
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mai 2021
mai 2025
29 juin 2024
The incidence of bone and joint infections (BJI) in children (osteomyelitis, septic
arthritis and spondylodiscitis) is 22 per 100,000 children in France. Every year, 3,000
children are hospitalized for BJI, 46% of whom are hospitalized for osteomyelitis. The
clinical pictures of BJI are varied: some are severe from the outset; others are
non-severe, such as BJIs in Kingella kingae, which are most common in children between
the ages of 6 months and 5 years. Currently, the management of children's BJI, regardless
of their severity, involves initial hospitalization to start intravenous antibiotic
therapy. This non-inferiority trial evaluates, in children with acute osteomyelitis with
no severity criteria, less invasive outpatient management with an oral antibiotic
treatment given at the outset compared to standard management.
Main objective : Demonstrate the non-inferiority of an ambulatory management strategy
versus a standard strategy involving hospitalization on complete recovery without relapse
at 6 months after an episode of acute osteomyelitis in children aged 1-4 years without
severity criteria.
Primary endpoint: Complete cure 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, periosteal abscess) before the end of antibiotic therapy
AND the absence of relapse or rehospitalization for osteomyelitis related to the initial
infection. This criterion will be assessed blindly by an adjudication committee.
Randomized controlled trial of non inferiority, with active control, in open
multi-center.
The control or experimental arm allocation (1:1 ratio) will be open-label of the
physician, patient and parents. This is a PROBE study: The evaluation of the main
judgment criterion will be carried out blindly by an adjudication committee.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Ambroise Paré | LORROT Mathie | 12/04/2024 09:27:34 | Contacter | ||
| AP-HP - Hôpital Antoine Béclère | LORROT Mathie | 12/04/2024 09:27:34 | Contacter | ||
| AP-HP - Hôpital Armand Trousseau-La Roche Guyon | LORROT Mathie | 12/04/2024 09:27:34 | Contacter | ||
| AP-HP - Hôpital Bicêtre | LORROT Mathie | 12/04/2024 09:27:34 | Contacter | ||
| AP-HP - Hôpital Jean Verdier | LORROT Mathie | 12/04/2024 09:27:34 | Contacter | ||
| AP-HP - Hôpital Louis Mourier | LORROT Mathie | 12/04/2024 09:27:34 | Contacter | ||
| AP-HP - Hôpital Necker-Enfants Malades | LORROT Mathie | 12/04/2024 09:27:34 | Contacter | ||
| AP-HP - Hôpital Robert Debré | LORROT Mathie | 12/04/2024 09:27:34 | Contacter | ||
| CHI DE CRETEIL | Sandra BISCARDI | 29/03/2024 01:29:42 | Contacter | ||
Critères
Tous
Inclusion Criteria:
Child ≥ 1 year and 4 years old ;
- 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 scan or MRI.
- Absence of severity criteria :
- Fever < 39°C
- AND absence of sepsis (absence of hemodynamic disorders, respiratory disorders,
consciousness disorders)
- AND absence of periosteal abscess or associated arthritis or deep vein
thrombosis
- AND absence of scarlatiniform rash (no gap of healthy skin)
- AND CRP < 50 mg/ml
- AND normal initial bone radiograph (or simple soft tissue thickening).
Child ≥ 1 year and 4 years old ;
- 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 scan or MRI.
- Absence of severity criteria :
- Fever < 39°C
- AND absence of sepsis (absence of hemodynamic disorders, respiratory disorders,
consciousness disorders)
- AND absence of periosteal abscess or associated arthritis or deep vein
thrombosis
- AND absence of scarlatiniform rash (no gap of healthy skin)
- AND CRP < 50 mg/ml
- AND normal initial bone radiograph (or simple soft tissue thickening).
- Multifocal osteoarticular infections
- Sickle cell or immunocompromised patients
- Antibiotic treatment in progress or within 48 hours prior to the emergency room
visit
- History of severe beta-lactam allergy (anaphylactic shock, angioedema)
- Digestive problems (vomiting or diarrhea)
- Refusal of parents to participate
- Parents (children) not affiliated to social security or without CMU
- Parents who do not speak French
- Participation in another intervention research protocol