null - FindTrial

N/A - POOMA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003522-25-FR

Enrollment

320

Registered

2019-12-11

Start date

2020-02-28

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute osteomyelitis of the child

Interventions

Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: AMOXICILLINE ACIDE CLAVULANIQUE 100mg/12.5 CAS Number: 26787-78-0 Pharmaceutical Form: Powder for solution for injection INN or Pr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Children = 1 year old and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Multifocal osteo-articular infections - Sickle cell patients, immunosuppressed - Antibiotic treatment in progress or within 48 hours before the emergency room consultation - Severe allergy to beta-lactamines - Digestive disorders

Design outcomes

Primary

Measure	Time frame
Main Objective: Demonstrate the non-inferiority of an outpatient management strategy versus a standard strategy involving hospitalization on complete recovery without relapse at 6 months after an episode of acute osteomyelitis of the 1-5 year old child without criteria of Gravity.;Secondary Objective: I.Compare outpatient management strategy versus standard strategy ?. Describe the clinical-biological and radiological characteristics of non-severe osteomyelitis in children ?. Studying the experience and satisfaction of families on their child's care journey at 1 month: satisfaction survey IV. Assess the efficiency of the outpatient strategy from the outpatient versus IV and then oral relay V.Make a medico-economic assessment of the budgetary impact of the generalization of the intervention;Primary end point(s): 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 re-hospitalization for osteomyelitis in relation to the initial infection. ;Timepoint(s) of evaluation of this end point: Mars 2024	—

Measure

Time frame

Main Objective: Demonstrate the non-inferiority of an outpatient management strategy versus a standard strategy involving hospitalization on complete recovery without relapse at 6 months after an episode of acute osteomyelitis of the 1-5 year old child without criteria of Gravity.;Secondary Objective: I.Compare outpatient management strategy versus standard strategy ?. Describe the clinical-biological and radiological characteristics of non-severe osteomyelitis in children ?. Studying the experience and satisfaction of families on their child's care journey at 1 month: satisfaction survey IV. Assess the efficiency of the outpatient strategy from the outpatient versus IV and then oral relay V.Make a medico-economic assessment of the budgetary impact of the generalization of the intervention;Primary end point(s): 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 re-hospitalization for osteomyelitis in relation to the initial infection. ;Timepoint(s) of evaluation of this end point: Mars 2024

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: Mars 2024	—

Countries

France

Contacts

Public ContactDRCI

AP-HP

fadila.amerali@aphp.fr01 44 84 17 17

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026