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 study about?

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.

1 joining the study

Upon joining the study, the patient will undergo an initial assessment to confirm eligibility. This includes verifying the presence of an infection related to the osteosynthesis material used after a long bone fracture.

The patient must have undergone surgical debridement, which is a procedure to clean the infected area, with either retention or removal of the implant.

2 treatment assignment

The patient will be randomly assigned to a treatment group. The study aims to compare the effectiveness of short versus long durations of antimicrobial therapy.

The specific antibiotics used will depend on the microorganism causing the infection. Options include moxifloxacin, amoxicillin sodium, daptomycin, cloxacillin, ampicillin, vancomycin, and others.

3 medication administration

Medications may be administered orally or intravenously, depending on the specific drug and treatment plan.

The frequency and dosage will be determined by the healthcare provider based on the patient’s condition and response to treatment.

4 monitoring and follow-up

Regular monitoring will be conducted to assess the patient’s response to treatment. This includes checking for the disappearance of infection symptoms and any side effects.

Follow-up visits will be scheduled to evaluate the patient’s recovery and the effectiveness of the treatment.

5 evaluation of outcomes

The primary outcome is the resolution of the infection without recurrence. Secondary outcomes include the development of any new infections, the need for additional surgeries, and the patient’s functional recovery.

The study will also monitor for any adverse effects and the development of antibiotic resistance.

6 completion of the study

The study is expected to conclude by December 31, 2027. At the end of the study, the patient’s overall health and recovery will be assessed.

The results will contribute to understanding the optimal duration of antimicrobial therapy for infections associated with osteosynthesis material.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Hospital El Bierzo Ponferrada Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario Principe De Asturias Alcala De Henares Spain
Hospital Universitario De Cruces Barakaldo Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Hospital Universitario Virgen De Valme Sevilla Spain
Hospital Universitario Lucus Augusti Lugo Spain
Servei De Salut De Les Illes Balears Palma Spain
Hospital Costa del Sol Marbella Spain
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
09.08.2022

Trial locations

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.

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 ID:
2023-508442-18-00
Protocol code:
DURATIOM
NCT ID:
NCT05294796
Trial Phase:
Therapeutic confirmatory (Phase III)

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