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 1

Conditions: Patients with long bone fractures who have had osteosynthesis material implanted to stabilize and assist fracturehealing and meet the criteria for Infections associated with osteosynthesis material
MedDRA version: 20.0Level: SOCClassification code: 10021881Term: Infections and infestations Class: 1
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: CTIS2023-508442-18-00

Lead Sponsor: Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 364

Inclusion Criteria

Patients >14 years of age., Stabilized fracture, even if unconsolidated., Controlled infection (absence of signs or symptoms of sepsis). Sepsis is defined as the presence of a score greater than or equal to 2 on the qSOFA or SOFA scale (Annex VII)., Early OM infection (that which occurs in the first 2 weeks after implant surgery) or delayed OM infection (that which occurs between 3 and 10 weeks after implant surgery)., Availability of antibiotics active against the isolated microorganism., Absence of bone exposure. Patients who initially had bone exposure but during the debridement surgery bonecoverage 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 or paternity, agree to use a highly effective birth control method during the treatment phase of the trial.

Exclusion Criteria

Late infections (those that occur more than 10 weeks after implant surgery)., Infections of the 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 (they are infections that are treated with different drugs and durations)., Patients in whom the debridement involves replacement of all the material in the same surgical time (These patients require a duration of antibiotic treatment of less than 8 weeks in all cases)., External fixative infections.