/A

Phase 1

• Conditions: acute osteomyelitis of the child; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-003522-25-FR
• Lead Sponsor: AP-HP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-11
• Last Update Posted: 11 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 320

Inclusion Criteria

-Children = 1 year old and <5 years old;
- First episode of acute osteomyelitis suspected on clinical arguments (functional impotence and pain of a limb/fever) and confirmed secondly by a bone scan or MRI
- Lack of severity criteria: Fever < 39°C, absence of sepsis (no hemodynamic disorders, respiratory disorders, disorder of consciousness), absence of abscess under periosta or associated arthritis, absence of scarlatiniform rash, CRP < 50 mg/ml, normal initial bone x-ray (or thickening of soft parts).

Are the trial subjects under 18? yes
Number of subjects for this age range: 320
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified