Acute non-severe osteomyelitis in children

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

15 Nov 2024 → ongoing

Decision date (initial)

2024-11-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

French Ministray of Health (PHRC-I AOR18076)

External identifiers

EU CT number

2024-516744-26-00

EudraCT number

2019-003522-25

ClinicalTrials.gov

NCT04554108

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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

Conditions and MedDRA coding

acute osteomyelitis of the child

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Children ≥ 1 year old and ≤4 years old;
2. 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
3. Absence of sepsis (absence of hemodynamic disorders, respiratory disorders, impaired consciousness)
4. And absence of subperiosteal abscess or associated arthritis or deep vein thrombosis
5. And absence of scarlatiniform rash
6. And CRP < 50 mg/ml
7. And normal initial bone x-ray (or thickening of soft parts).

Exclusion criteria 5

1. Infections ostéo-articulaires multifocales
2. Sickle cell patients, immunosuppressed
3. Antibiotic treatment in progress or within 48 hours before the emergency room consultation
4. Severe allergy to beta-lactamines
5. Digestive disorders

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Coordinating investigator

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Coordinating investigator

Locations

1 EU/EEA country · 34 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications