RIFAMPICIN for Infection associated with osteosynthesis material (implant-associated infection) after long bone fracture

Inclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}

Exclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- Due to clinical failure in OCD evaluation:\n- Non-disappearance or return to baseline of all initial clinical criteria.\n- Non-disappearance of symptoms and signs of infection.\n- Appearance of new infection symptoms.\n- Need to suspend antibiotic or add another due to lack of effectiveness.\n- In debridement is performed with retention: intraoperative and BM sonication cultures when removing BM when the fracture consolidates.\n- Use of the REBORNE fracture consolidation scale.","definition_or_measurement_approach":"Composite clinical failure assessed by persistence/return of clinical infection criteria, appearance of new infection symptoms, need to stop or change antibiotics for lack of effectiveness; where applicable intraoperative and sonication cultures on implant removal and fracture consolidation assessment using the REBORNE fracture consolidation scale."}

Secondary endpoints

• {"endpoint_text":"- Clinical variable: -Efficacy of each group of antibiotics -Development of secondary infections -Recurrence rate (recurrences and reinfections) -Need for new surgeries (debridement, removal of material, coverage, amputation). -Evaluation of different reconstruction strategies (bone and soft tissue) carried out in order to recover lost functionality. -Functional status (defined as the recovery of the functionality of the extremity prior to the fracture) and quality of life.","definition_or_measurement_approach":"Clinical endpoints measured by efficacy per antibiotic group, incidence of secondary infections, recurrence/reinfection rates, record of subsequent surgeries, assessment of reconstruction strategies, functional recovery and quality-of-life measures (instruments not specified in extracted data)."}
• {"endpoint_text":"- Microbiological variable: -Development of resistance during treatment. -C. difficile infection during or 30 days after treatment","definition_or_measurement_approach":"Microbiological monitoring including culture results and resistance development during treatment; monitoring for C. difficile infection during treatment and up to 30 days post-treatment."}
• {"endpoint_text":"- Adverse effects and complications: Occurrence of adverse events (frequency and severity), including death (ie, all-cause mortality).","definition_or_measurement_approach":"Safety monitoring of adverse events and complications with recording of frequency and severity, including all-cause mortality."}
• {"endpoint_text":"- Consumption of health resources: The consumption of health resources will be evaluated for each treatment group: days of antibiotic treatment, hospital stay, readmissions, number of surgeries performed.","definition_or_measurement_approach":"Health-resource use measured by days of antibiotic therapy, length of hospital stay, readmissions, and number of surgeries per patient/group."}

Spain

Earliest CTIS Part Ii Submission Date

25-09-2023

Latest Decision Or Authorization Date

11-04-2025

Processing Time Days

564

Number Of Sites

27

Number Of Participants

364

Primary sponsor

Full Name

Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain