InfectionsPhase 3DURATIOMNCT05294796
Efficacy and Safety of Antimicrobial Durations Treatment of Infections Associated With Osteosynthesis Material
A Phase 3 study testing Short course of antibiotherapy and Long course of antibiotherapy in people with Infections, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 29 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Infections
- What is being tested?
- Short course of antibiotherapy and Long course of antibiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 29 sitesSpain
- Study dates
- 9 Aug 2022to Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age greater than or equal to 14 years.
- 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
Who cannot join
- Late infections
- 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.
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- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Spain29 sites, 28 recruiting
- Recruiting
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, 28805
José María Barbero Allende, j_m_barbero@yahoo.es
José María Barbero Allende
- Recruiting
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Esteban Alberto Reynaga Sosa, eareynaga.germanstrias@gencat.cat
Esteban Alberto Reynaga Sosa
- Recruiting
Hospital Universitario de Cruces
Barakaldo, Vizcaya, 48903
Laura Guio Carrión, LAURA.GUIOCARRION@osakidetza.eus
Laura Guio Carrión
- Recruiting
Hospital del Mar
Barcelona, 08003
Luisa Sorlí Redó, lsorli@psmar.cat
Luisa Sorlí Redó
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 08035
María Dolores Rodríguez Pardo, dolorodriguez@vhebron.net
María Dolores Rodríguez Pardo
- Recruiting
Hospital Universitario Clinic de Barcelona
Barcelona, 08036
Laura Morata Ruiz, LMORATA@clinic.cat
Laura Morata ruiz
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Natividad de Benito Hernández, nbenito@santpau.cat
Natividad de Benito Hernández
- Recruiting
Hospital Universitari de Bellvitge
Barcelona, 08907
Oscar Murillo Rubio, omurillo@bellvitgehospital.cat
Oscar Murillo Rubio
- Recruiting
Hospital Universitario Puerto Real
Cadiz, 11510
Alberto Romero Palacios, alberpalacios@hotmail.com
Alberto Romero Palacios
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Javier Martínez Ros, javiermartinezros1985@gmail.com
Javier Martínez Ros
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada, 18014
Concepción Fernández Roldán, frconcha@yahoo.es
Concepción Fernández Roldán
- Recruiting
Hospital Universitario Jerez de la Frontera
Jerez de la Frontera, Cádiz, 11407
Virginia Corbacho Sánchez, vcorbacho@gmail.com
Virginia Corbacho Sánchez
- Recruiting
Hospital San Pedro
Logroño, La Rioja, 26006
José Ramon Blanco Ramos, jrblanco@riojasalud.es
José Ramón Blanco Ramos
- Recruiting
Hospital Universitario Lucus Augusti
Lugo, 27003
María José García País, maria.jose.garcia.pais@sergas.es
María José García País
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
Javier Cobo Reinoso, javier.cobo@salud.madrid.org
Javier Cobo Reinoso
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Antonio Blanco García, ablancog@fjd.es
Antonio Blanco García
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Jaime Lora-Tamayo Morillo-Velarde, sirsilverdelea@yahoo.com
Jaime Lora-Tamayo Morillo-Velarde
- Terminated
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Regional Universitario de Málaga
Málaga, 29010
Beatriz Sobrino Díaz, bea_sobrino@yahoo.es
Beatriz Sobrino Díaz
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Enrique Nuño Álvarez, enrique.nuno@gmail.com
Enrique Nuño Álvarez
- Recruiting
Hospital Universitario Costa del Sol
Málaga, 29603
Alfonso del Arco Jiménez, alfarco@gmail.com
Alfonso del Arco Jiménez
- Recruiting
Hospital Universitario Son Espases
Palma, Balearic Islands, 07120
Helem Haydeen Vilchez Rueda, helemh.vilchez@ssib.es
Helem Haydeen Vilchez Rueda
- Recruiting
Hospital Universitario El Bierzo
Ponferrada, León, 24404
Alberto Bahamonde Carrasco, abahamonde@saludcastillayleon.es
Alberto Bahamonde Carrasco
- Recruiting
Hospital Universitario Parc Taulí
Sabadell, Barcelona, 08208
Eva Van den Eynde Otero, evandeneynde@tauli.cat
Eva Van den Eynde Otero
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Marta Fernández Sampedro, marta.fernandezs@scsalud.es
Marta Fernández Sampedro
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, Seville, 41013
José Manuel Lomas Cabezas, jlomascabezas@yahoo.es
Jose Manuel Lomas Cabezas
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
Clara Rosso Fernández, 955012144, clara.rosso.sspa@juntadeandalucia.es
Irene Borreguero Borreguero, 955007609, irene.borreguero@juntadeandalucia.es
- Recruiting
Hospital Universitario Virgen de Valme
Seville, 41014
Juan E Corzo Delgado, juanecorzo@telefonica.neT
Juan E Corzo Delgado
- Recruiting
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009
José Ramón Paño Pardo, joserrapa@gmail.com
José Ramón Paño Pardo
About this study
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.
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.
Read the detailed description
Orthopedic implants for fracture fixation or osteosynthesis material are used for internal fixation of fractures, allowing their stability and consolidation.
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
- Infections
- Being tested
- Short course of antibiotherapy, Long course of antibiotherapy
- Keywords
- Infections associated with osteosynthesis material, Fracture-related infection, Long bone fractures, Antibiotics duration, Antimicrobial therapy, Multidrug-resistant bacteria, Biofilm fracture healing, Antibiotic toxicity, Investigator-driven clinical trial
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short course of antibiotherapyCombination product
Short duration of authorized antibiotic therapy according to its data sheet in infections associated with osteosynthesis material
Long course of antibiotherapyCombination product
Long duration of authorized antibiotic therapy according to its data sheet in infections associated with osteosynthesis material
| Study group | Role | What they receive |
|---|---|---|
| Short course of antibiotherapy | Active comparator | 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) Receives: Combination Product: Short course of antibiotherapy |
| Long course of antibiotherapy | Active comparator | 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 Receives: Combination Product: Long course of antibiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinical cure in the test of cure
A success at the test of cure is the resolution of infection symptoms, the absence of clinical signs and symptoms of infection (persistence of symptoms of infection, relapse of infection after a period without symptoms, or superinfection by a different microorganism) without antibiotic therapy and with C-reactive protein <10 mg/L (unless another cause justifies a higher C-reactive protein value); If the patient dies, when the death was not related to the infection; and no need for chronic suppressive antibiotic therapy to "control" of the infection.
Measured: 12 months after completion of antimicrobial treatment
Radiological healing in the test of cure
Radiological healing is defined as the presence of radiological signs of fracture consolidation (plain radiographic or CT) of the infected bone. Non-union or absence of consolidation of a fractured bone is defined when it has not completely healed within 9 months after osteosynthesis surgery or when it has not shown progression towards fracture callus formation in 3 consecutive months on serial radiographs.
The REBORNE fracture healing scale will be used for a more accurate assessment of fracture healing on radiographs, or CT if necessary.
Measured: 12 months after completion of antimicrobial treatment
Definitive soft tissue coverage at test of cure
Number of patients who present definitive soft tissue coverage at test of cure
Measured: 12 months after completion of antimicrobial treatment
Secondary outcomes (10)
Efficacy of each group of antibiotics
Number of days of antibiotic administration
Measured: 12 months from the start of antibiotic treatment
Performance of an antibiogram to assess the development of antimicrobial resistance
Standard microbiological techniques will be used to identify microorganisms recovered and to determine antimicrobial susceptibility according to EUCAST recommendation (EUCAST guidelines for detection of resistance mechanisms and specific resistances of clinical and/or epidemiological importance, Version 2.0, 2017) https://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Resistance_mechanisms/EUCAST_detection_of_resistance_mechanisms_170711.pdf
Measured: 8 months and 12 months
Surgical wound culture to assess the development of secondary infections
To evaluate the appearance of secondary infections during antibiotic treatment that standard microbiological techniques will be used to identify microorganisms recovered and to determine antimicrobial susceptibility according to EUCAST recommendation (EUCAST guidelines for detection of resistance mechanisms and specific resistances of clinical and/or epidemiological importance, Version 2.0, 2017) https://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Resistance_mechanisms/EUCAST_detection_of_resistance_mechanisms_170711.pdf
Measured: 8 months and 12 months
Recurrence rate
To evaluate the recurrence rate during antibiotic treatment.
Measured: 8 months and 12 months
Evaluate the need for new surgeries, such as debridement, removal of material, coverage or amputation, through radiological evaluation of fracture union.
To evaluate the need for new surgeries through radiological evaluation
Measured: Day 28, week 8, week 12, month 6 and month 12.
Evaluation of the functional status, defined as the recovery of the functionality of the limb prior to the fracture, by completing the Quick Disabilities of Arm, Shoulder and Hand questionnaire.
The functional state, normal or reduced, will be evaluated with respect to the situation prior to the fracture. Lower extremity mobility is classified as: walks unassisted; with 1 cane; with 2 canes; with walker; "wander home alone"; not wandering..
Measured: 6 months and 12 months (visit 6 and 7)
Evaluation the consumption of health resources
Total number and posology of all the antibiotics that have been administered to the patient will be taken into account, in addition to the new surgeries, new microbiological cultures and hospitalizations that have been required.
Measured: Month 12
Evaluate the number of patients who have required any of the bone or soft tissue reconstruction strategies.
Total number of new surgeries for better bone or soft tissue coverage: number of vacuum therapies (VAC or PICO), total number of grafts or flaps needed by the patient throughout the study.
Measured: Month 12
Presentation of adverse events (frequency and severity).
Number of adverse events (frequency and severity) that have happened during the study.
Measured: Through study completion (12 months)
Clostridium difficile infection
Number of cases observed during antibiotic treatment or 30 days after completion.
Measured: During treatment or 30 days after completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start9 Aug 2022
- Primary completionOct 2024 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic, multicenter, non-inferiority, open labelled, randomized trial comparing different durations of antibiotherapy in osteosynthesis material infections after long bone fractures treated with debridement and material retention (see design algorithm and inclusion criteria). The CONSORT extension for pragmatic designs will be used.
- Masking
- None (open label)
- Enrolment
- 364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- María Dolores del Toro López, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294796
- Sponsor's protocol ID
- DURATIOM
- Acronym
- DURATIOM
- Status last verified
- Mar 2024
- First submitted
- 26 Jan 2022
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37216357
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05294796
- Acronym / sponsor ID
- DURATIOM / DURATIOM
- Conditions
- Infections
- Keywords
- Infections associated with osteosynthesis material, Fracture-related infection, Long bone fractures, Antibiotics duration, Antimicrobial therapy, Multidrug-resistant bacteria, Biofilm fracture healing, Antibiotic toxicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Orthopedic implants for fracture fixation or osteosynthesis material are used for internal fixation of fractures, allowing their stability and consolidation.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic, multicenter, non-inferiority, open labelled, randomized trial comparing different durations of antibiotherapy in osteosynthesis material infections after long bone fractures treated with debridement and material retention (see design algorithm and inclusion criteria). The CONSORT extension for pragmatic designs will be used.
| Arm | Type | Receives |
|---|---|---|
| Short course of antibiotherapy | Active comparator | Combination Product: Short course of antibiotherapyPatients 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) |
| Long course of antibiotherapy | Active comparator | Combination Product: Long course of antibiotherapyPatients 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 |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age greater than or equal to 14 years.
- 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.
Key exclusion criteria (9 listed)
- Late infections
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short course of antibiotherapyShort duration of authorized antibiotic therapy according to its data sheet in infections associated with osteosynthesis material | Combination product | Short course of antibiotherapy |
| Long course of antibiotherapyLong duration of authorized antibiotic therapy according to its data sheet in infections associated with osteosynthesis material | Combination product | Long course of antibiotherapy |
Primary outcome
Number of participants with clinical cure in the test of cure
Time frame: 12 months after completion of antimicrobial treatment
A success at the test of cure is the resolution of infection symptoms, the absence of clinical signs and symptoms of infection (persistence of symptoms of infection, relapse of infection after a period without symptoms, or superinfection by a different microorganism) without antibiotic therapy and with C-reactive protein <10 mg/L (unless another cause justifies a higher C-reactive protein value); If the patient dies, when the death was not related to the infection; and no need for chronic suppressive antibiotic therapy to "control" of the infection.
Radiological healing in the test of cure
Time frame: 12 months after completion of antimicrobial treatment
Radiological healing is defined as the presence of radiological signs of fracture consolidation (plain radiographic or CT) of the infected bone. Non-union or absence of consolidation of a fractured bone is defined when it has not completely healed within 9 months after osteosynthesis surgery or when it has not shown progression towards fracture callus formation in 3 consecutive months on serial radiographs. The REBORNE fracture healing scale will be used for a more accurate assessment of fracture healing on radiographs, or CT if necessary.
Definitive soft tissue coverage at test of cure
Time frame: 12 months after completion of antimicrobial treatment
Number of patients who present definitive soft tissue coverage at test of cure
10 secondary outcomes
Efficacy of each group of antibiotics
Time frame: 12 months from the start of antibiotic treatment
Performance of an antibiogram to assess the development of antimicrobial resistance
Time frame: 8 months and 12 months
Surgical wound culture to assess the development of secondary infections
Time frame: 8 months and 12 months
Recurrence rate
Time frame: 8 months and 12 months
Evaluate the need for new surgeries, such as debridement, removal of material, coverage or amputation, through radiological evaluation of fracture union.
Time frame: Day 28, week 8, week 12, month 6 and month 12.
Evaluation of the functional status, defined as the recovery of the functionality of the limb prior to the fracture, by completing the Quick Disabilities of Arm, Shoulder and Hand questionnaire.
Time frame: 6 months and 12 months (visit 6 and 7)
Evaluation the consumption of health resources
Time frame: Month 12
Evaluate the number of patients who have required any of the bone or soft tissue reconstruction strategies.
Time frame: Month 12
Presentation of adverse events (frequency and severity).
Time frame: Through study completion (12 months)
Clostridium difficile infection
Time frame: During treatment or 30 days after completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Derived from this study: PubMed 37216357Garrigos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Dolores del Toro López principal investigator
Hospital Universitario Virgen Macarena
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Short course of antibiotherapy and Long course of antibiotherapy in people with Infections, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 29 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clara Rosso Fernández (955012144, clara.rosso.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with clinical cure in the test of cure (time frame: 12 months after completion of antimicrobial treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05294796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.