Efficacy and Safety of Antimicrobial Durations Treatment of Infections Associated With Osteosynthesis Material
NCT ID: NCT05294796
Last Updated: 2024-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
364 participants
INTERVENTIONAL
2022-08-09
2026-04-30
Brief Summary
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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.
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Detailed Description
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Infection associated with osteosynthesis material is one of the most feared and challenging complications of trauma surgery and can lead to total loss of function or amputation of the limb, when complete recovery is to be expected without infection. Furthermore, they involve excessive consumption of antimicrobials, with inadequate prescriptions and prolonged durations that favour superinfections by multidrug-resistant microorganisms, in addition to the drug-related toxicities, especially diarrhea due to Clostridium difficile. Most studies and recommendations on the management of orthopedic implant-associated infections have focused on prosthetic joint infections, and while they share similarities with Infections Associated With Osteosynthesis Material Implanted, there are major differences in terms of risk factors, diagnosis, treatment, and prevention. While the extrapolation of knowledge from prosthetic joint infections to the field of Infections Associated With Osteosynthesis Material Implanted has helped orthopedic surgeons and internists/infectologists in their management, there are large gaps and unanswered questions that represent a new challenge for research in this field. One of these challenges, and focusing on the field of infection treatment, is the search for the best surgical procedure according to the age of the implant and fracture healing, to determine the duration of antibiotic treatment and whether it should be maintained until fracture healing, and which is the most appropriate treatment in each of the scenarios.
The identification of conditions in which the duration of the antimicrobial treatment can be shortened, and in case of prolonged treatments, which antimicrobial has the best safety profile and less impact on the induction of bacterial resistances is of special interest, due to the frequent appearance of toxicities and the increase of bacterial resistances and superinfections by multidrug-resistant bacteria.
If the hypothesis of non-inferiority of short vs. long antibiotic treatments is demonstrated, and the efficacy of antibiotics with less ecological impact in long treatments, the impact on reduction of bacterial resistance, toxicity and health costs will be observed. The project also aims to promote quality and multidisciplinary care, homogenising clinical practice in the management of Infections Associated With Osteosynthesis Material Implanted based on scientific knowledge. Early and personalised patient care with Infections Associated With Osteosynthesis Material Implanted allows for faster recovery, both clinically and functionally, enabling earlier mobility recovery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Short course of antibiotherapy
Patients enrolled in this arm, will receive 8 weeks of antibiotherapy in case of early infection (\< 2 week), and 12 weeks of antibiotherapy in case of delayed infection (2-10 weeks)
Short course of antibiotherapy
Short duration of authorized antibiotic therapy according to its data sheet in infections associated with osteosynthesis material
Long course of antibiotherapy
Patients enrolled in this arm, will receive 12 weeks of antibiotherapy in case of early infection (\< 2 week), and until fracture healing of antibiotherapy in case of delayed infection
Long course of antibiotherapy
Long duration of authorized antibiotic therapy according to its data sheet in infections associated with osteosynthesis material
Interventions
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Short course of antibiotherapy
Short duration of authorized antibiotic therapy according to its data sheet in infections associated with osteosynthesis material
Long course of antibiotherapy
Long duration of authorized antibiotic therapy according to its data sheet in infections associated with osteosynthesis material
Eligibility Criteria
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Inclusion Criteria
* Stable fracture, even if unconsolidated.
* Controlled infection (absence of signs or symptoms of sepsis).
* Early or delayed infection.
* Availability of antibiotics active against the isolated microorganism.
* Absence of bone exposure. Patients who initially had bone exposure but during the debridement surgery bone coverage was performed by any method (skin approximation, grafting, vacuum therapy) can be included in the criteria.
* Signed written informed consent.
* If there is a possibility of pregnancy (in women of childbearing potential) or paternity, agree to use a highly effective method of birth control recommended by the Clinical Trial Facilitation Group (CTFG) during the treatment phase of the trial
Exclusion Criteria
* Infections of osteosynthesis material in non-long bones.
* 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.
* Pregnant or lactating women.
* Patients in whom there may be drug interactions or contraindications described in the technical data sheets of the investigational drugs used in this trial.
* Infections due to mycobacteria, fungi and parasites (since they are infections that are treated with drugs and for different durations).
* Patients in whom all the material is replaced during the debridement at the same surgical time (since these patients require antibiotic treatment for less than 8 weeks in all cases).
* Infections of external fixators.
14 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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María Dolores del Toro López
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen Macarena
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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Garrigos C, Rosso-Fernandez CM, Borreguero I, Rodriguez P, Garcia-Albea R, Bravo-Ferrer JM, Rodriguez-Bano J, Del Toro MD; DURATIOM team. Efficacy and safety of different antimicrobial DURATions for the treatment of Infections associated with Osteosynthesis Material implanted after long bone fractures (DURATIOM): Protocol for a randomized, pragmatic trial. PLoS One. 2023 May 22;18(5):e0286094. doi: 10.1371/journal.pone.0286094. eCollection 2023.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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DURATIOM
Identifier Type: -
Identifier Source: org_study_id
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