Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, Spain
Recruiting
Study on the Effectiveness of Moxifloxacin and Drug Combination for Treating Bone Implant Infections in Patients with Long Bone Fractures
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying infections that occur in the material used to stabilize and heal long bone fractures, known as osteosynthesis material. These infections can happen after surgery when the material is implanted to help the bone heal. The study aims to determine if a shorter course of treatment is as effective as a longer one in managing these infections. The trial involves patients who have undergone surgical procedures to either keep or remove the implant, combined with targeted antimicrobial therapy, which is a treatment using specific antibiotics to fight the infection.
The antibiotics being studied in this trial include moxifloxacin, amoxicillin sodium, daptomycin, cloxacillin, ampicillin, vancomycin, sulfamethoxazole, trimethoprim, meropenem, rifampicin, ceftriaxone, ciprofloxacin, linezolid, clindamycin, teicoplanin, ceftazidime, cefepime, and levofloxacin. Some of these medications are given orally, while others are administered intravenously, which means they are injected directly into a vein. The study will compare the effectiveness and safety of these antibiotics in treating the infections associated with the osteosynthesis material.
Participants in the study will receive either the standard treatment duration or a shorter one, and their progress will be monitored to see how well the infection is controlled. The study will also look at the development of any new infections, the need for additional surgeries, and the overall recovery of the patient's limb function and quality of life. The trial is expected to continue until the end of 2027, with the goal of providing valuable information on the best treatment strategies for these types of infections.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
9 criteria
- Must be at least 14 years old.
- Fracture must be stabilized, even if it hasn't fully healed.
- Infection must be controlled, meaning no signs or symptoms of a severe infection called **sepsis**.
- Infection must have occurred early (within the first 2 or 3 weeks after implant surgery) or delayed (between 3 and 10 weeks after implant surgery).
- There must be antibiotics available that work against the specific germs causing the infection.
- No exposed bone should be present. If there was exposed bone initially, it must have been covered during surgery using methods like skin approximation, grafting, or vacuum therapy.
- Must have signed the informed consent form. If underage, a legal guardian must sign, and the minor must agree as well.
- If there is a chance of becoming pregnant or fathering a child, must agree to use a highly effective birth control method during the trial.
- Infections of the material used to stabilize the bone after a corrective surgery called **osteotomy** may be included.
Who cannot join the trial?
5 criteria
- Patients who do not have an infection related to the **osteosynthesis material**. This is the material used to stabilize and help heal a broken bone.
- Patients who are not undergoing **surgical debridement**. This is a procedure where infected or damaged tissue is removed.
- Patients who are not receiving **targeted antimicrobial therapy**. This is a treatment using specific medications to fight infections.
- Patients who do not have a **long bone fracture**. Long bones are the larger bones in the body, like those in the arms and legs.
- Patients who are not treated with either **implant retention** or **implant removal**. Implant retention means keeping the material in place, while implant removal means taking it out.
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Verified sites
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Hospital Clinic De Barcelona
VerifiedBarcelona, SpainHospital Costa del Sol
VerifiedMarbella, Spain
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Investigated drugs
DURATIOM: This is a clinical trial focused on evaluating the effectiveness and safety of different durations of antimicrobial treatments for infections related to osteosynthesis material, which is used in surgeries for long bone fractures. The trial aims to determine if a shorter course of treatment is as effective as a longer one after surgical procedures like debridement with implant retention or removal.
What is already known about the treatment
Antimicrobial Therapy – This medication is administered orally or intravenously, depending on the specific drug used in the treatment. It is currently being studied in clinical trials to determine the optimal duration of therapy for infections associated with osteosynthesis material after long bone fractures. The main therapeutic indication is to treat infections that occur around the implanted material used to stabilize bone fractures. The mechanism of action involves targeting and eliminating bacteria that cause these infections, often by disrupting bacterial cell walls or inhibiting protein synthesis. This medication falls under the pharmacological classification of antibiotics, which are used to combat bacterial infections.
Investigated diseases
Infections Associated with Osteosynthesis Material – This condition occurs when bacteria infect the metal or other materials used to stabilize a bone fracture. The infection can develop soon after surgery or even months later. Symptoms may include redness, swelling, and pain at the site of the implant, along with fever. The infection can hinder the healing process of the fracture and may lead to the loosening of the implant. Treatment often involves surgical cleaning of the infected area, with either retention or removal of the implant, and targeted antimicrobial therapy. The progression of the disease depends on the effectiveness of the surgical and antimicrobial interventions.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508442-18-00Protocol codeDURATIOMEstimated enrolment364 patientsSponsorFundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
sourced from the EU Clinical Trials Register and site verification
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