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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.
EU CTIS ID: 2023-508442-18-00
What this study is testing
To evaluate whether, after performing surgical treatment (debridement with implant retention or debridement with implant removal) in patients with IOM due to a large bone fracture, a short treatment is as effective as a longer treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Inclusion criteria when performing DAIR (implant retention): the CI (9) are listed below: 1. Age greater than or equal to 14 years. 2. Stabilized fracture, even non-consolidated. 3. Controlled infection (absence of signs or symptoms of sepsis). 4. Early BM infection (that occurs in the first 2 weeks after implant surgery) or delayed BM infection (that occurs between 3 and 10 weeks after implant surgery). 5. Availability of antibiotics active against the isolated microorganism. 6. Absence of bone exposure. Patients who initially had bone exposure, but during debridement surgery, bone coverage was performed by any method (skin approximation, grafting, vacuum therapy) may be included in the criteria. 7. Patients who have signed the informed consent, in the case of minors, signature of the legal guardians and assent of the minor. 8. If there is a possibility of pregnancy or parenthood, agree to the use of a highly effective method of birth control during the treatment phase of the trial. 9. Infections of osteosynthesis material implanted after an osteotomy due to corrective surgery may be included.
- Inclusion criteria when implant removal is performed: the CI (9) are listed below: 1. Age greater than or equal to 14 years. 2. Controlled infection (absence of signs or symptoms of sepsis). 3. Early BM infection (that occurs in the first 3 weeks after implant surgery) or delayed BM infection (that occurs between 4 and 10 weeks after implant surgery). 4. Availability of antibiotics active against the isolated microorganism. 5. Absence of bone exposure. Patients who initially had bone exposure, but during the debridement and material removal surgery, bone coverage was performed by any method (skin approximation, graft, vacuum therapy), can be included in the criteria. 6. Patients who have signed the informed consent, in the case of minors, signature of the legal guardians and assent of the minor. 7. Patients may be included if DAIR was performed in the first surgery, but subsequently decided to remove the implant, as long as the rest of the inclusion criteria are met. 8. If there is a possibility of pregnancy or parenthood, agree to the use of a highly effective method of birth control during the treatment phase of the trial. 9. Infections of osteosynthesis material implanted after an osteotomy due to corrective surgery may be included.
You likely can't join if
- Exclusion criteria when performing DAIR (implant retention): the CE (9) are listed below: 1. Late infections (those that occur more than 10 weeks after implant surgery). 2. Infections of osteosynthesis material in non-long bones. 3. Infections of the revision osteosynthesis material or that occur after previous surgeries. 4. Patients in whom it is unlikely to complete follow-up for at least 1 year after completing antibiotic treatment. 5. Pregnant or breastfeeding women. 6. Patients in whom there may be interactions with medications or contraindications described in the technical sheets of the investigational medications used in this trial. 7. Infections due to mycobacteria, fungi and parasites. 8. Patients in whom all the material is replaced during the debridement at the same surgical time. 9. Infections of external fixators.
- Exclusion criteria when performing DAIR with REMOVAL of the implant): the CE (10) are listed below: 1. Late infections (those that occur more than 10 weeks after implant surgery). 2. Infections of osteosynthesis material in non-long bones. 3. Infections of the revision osteosynthesis material or that occur after previous surgeries. 4. Inability to perform a good debridement, bone curettage, or resection in the presence of osteomyelitis. 5. Infections treated with removal of the implant but in which the reimplantation of a new osteosynthesis material is performed in the same surgical procedure. 6. Patients in whom it is unlikely to complete follow-up for at least 1 year after completing antibiotic treatment. 7. Pregnant or breastfeeding women. 8. Patients in whom there may be interactions with medications or contraindications described in the technical sheets of the investigational medications used in this trial. 9. Infections due to mycobacteria, fungi and parasites. 10. Infections of external fixators.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.