Efficacy and Safety of Antimicrobial Durations Treatment of Infections Associated With Osteosynth… (NCT05294796) | Clinical Trial Compass
UnknownPhase 3
Efficacy and Safety of Antimicrobial Durations Treatment of Infections Associated With Osteosynthesis Material
Spain364 participantsStarted 2022-08-09
Plain-language 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.
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.
Who can participate
Age range
14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 surgica…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with clinical cure in the test of cure
Timeframe: 12 months after completion of antimicrobial treatment
2
Radiological healing in the test of cure
Timeframe: 12 months after completion of antimicrobial treatment
3
Definitive soft tissue coverage at test of cure
Timeframe: 12 months after completion of antimicrobial treatment
Trial details
NCT IDNCT05294796
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla