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RECRUITING
NCT05294796
PHASE3

Efficacy and Safety of Antimicrobial Durations Treatment of Infections Associated With Osteosynthesis Material

Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

View on ClinicalTrials.gov

Summary

Infections associated with osteosynthesis material are among the most feared and challenging complications of trauma surgery and can lead to total function loss or limb amputation when complete recovery is to be expected without infection. This is a clinical trial with the purpose of evaluate the optimal duration of antibiotic therapy in Infections Associated With Osteosynthesis Material Implanted when implant is retained.

Official title: Efficacy and Safety of Different Antimicrobial Durations for the Treatment of Infections Associated With Osteosynthesis Material Implanted After Long Bone Fractures (DURATIOM). Phase 3 Pragmatic Multicenter Open Labelled Randomized Trial.

Key Details

Gender

All

Age Range

14 Years - Any

Study Type

INTERVENTIONAL

Enrollment

364

Start Date

2022-08-09

Completion Date

2026-04

Last Updated

2024-08-30

Healthy Volunteers

No

Conditions

Interventions

COMBINATION_PRODUCT

Short course of antibiotherapy

Short duration of authorized antibiotic therapy according to its data sheet in infections associated with osteosynthesis material

COMBINATION_PRODUCT

Long course of antibiotherapy

Long duration of authorized antibiotic therapy according to its data sheet in infections associated with osteosynthesis material

Locations (29)

Hospital Universitario Son Espases

Palma, Balearic Islands, Spain

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario Parc Taulí

Sabadell, Barcelona, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario Jerez de la Frontera

Jerez de la Frontera, Cádiz, Spain

Hospital San Pedro

Logroño, La Rioja, Spain

Hospital Universitario El Bierzo

Ponferrada, León, Spain

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Hospital Universitario Virgen del Rocío

Seville, Seville, Spain

Hospital Universitario de Cruces

Barakaldo, Vizcaya, Spain

Hospital del Mar

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Universitario Clinic de Barcelona

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitari de Bellvitge

Barcelona, Spain

Hospital Universitario Puerto Real

Cadiz, Spain

Hospital Universitario Virgen de las Nieves

Granada, Spain

Hospital Universitario Lucus Augusti

Lugo, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Regional Universitario de Málaga

Málaga, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario Costa del Sol

Málaga, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitario Virgen de Valme

Seville, Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain