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Evaluating antibiotic duration for infections related to bone implants

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.

Phase 3 Interventional Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · NCT05294796

This study is testing how long people with stable fractures and infections related to bone implants should take antibiotics to see which duration works best for their recovery.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment364 (estimated)
Ages14 Years and up
SexAll
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla Academic / other
Locations29 sites (Badalona, Barcelona and 28 other locations)
Trial IDNCT05294796 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine the optimal duration of antibiotic therapy for infections associated with osteosynthesis material in patients with stable fractures. It focuses on patients who have controlled infections and evaluates the efficacy of both short and long courses of antibiotic treatment. The study addresses a significant gap in current medical knowledge regarding the management of infections related to orthopedic implants, which can lead to severe complications if not treated appropriately. By comparing different treatment durations, the trial seeks to improve patient outcomes and reduce the risk of complications such as superinfections and antibiotic resistance.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 14 and older with stable fractures and controlled infections related to osteosynthesis material.

Not a fit: Patients with late infections or those with infections of non-long bone osteosynthesis material will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment protocols for infections associated with bone implants, improving recovery rates and reducing complications.

How similar studies have performed: While there have been studies on prosthetic joint infections, this approach specifically targeting infections associated with osteosynthesis material is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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.

Where this trial is running

Badalona, Barcelona and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions InfectionsInfections associated with osteosynthesis materialFracture-related infectionLong bone fracturesAntibiotics durationAntimicrobial therapyMultidrug-resistant bacteriaBiofilm fracture healing
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.