Different antimicrobial durations for the treatment of infections associated with OsteosynthesisMaterial implanted after long bone fractures

Phase 1

• Conditions: Patients with long bone fractures who have had osteosynthesis material implanted to stabilize and assist fracturehealing and meet the criteria for Infections associated with osteosynthesis material; MedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2021-003914-38-ES
• Lead Sponsor: Fundación Pública Andaluza para la Gestión de la Investigación

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-01
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 378

Inclusion Criteria

-Patients >14 years of age
-Stable fracture, even if unconsolidated.
-Controlled infection (absence of signs or symptoms of sepsis).
-Early or delayed infection (see definitions below).
-Availability of antibiotics active against the isolated microorganism.
-Absence of bone exposure. Patients who initially had bone exposure but during the debridement surgery bonecoverage was performed by any method (skin approximation, grafting, vacuum therapy) can be included in the criteria.
-Signed written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 182
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 91

Exclusion Criteria

- Late infections
- Infections of revision osteosynthesis material or occurring after previous surgeries.
- Patients who are not expected to be followed up for at least 1 year after completion of antibiotic treatment.

Study & Design

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