Different antimicrobial durations for the treatment of infections associated with Osteosynthesis Material implanted after long bone fractures

Efficacy and safety of different antimicrobial DURATions for the treatment of infections associated with Osteosynthesis Material implanted after long bone fractures (DURATIOM). Phase 4 pragmatic multicenter open labelled randomized trial. - DURATIOM

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003914-38-ES

Enrollment

378

Registered

2021-12-01

Start date

2022-02-14

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with long bone fractures who have had osteosynthesis material implanted to stabilize and assist fracture healing and meet the criteria for Infections associated with osteosynthesis material MedDRA version: 20.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Ampicillim Product Name: Ampicillim Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Ampicillin Other descriptive name: AMPICILLIN, ANHYDROUS Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients >14 years of age -Stable fracture, even if unconsolidated. -Controlled infection (absence of signs or symptoms of sepsis). -Early or delayed infection (see definitions below). -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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 182 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 91

Exclusion criteria

Exclusion criteria: - Late infections - 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate whether, after performing surgical debridement in patients with IOM due to a large bone fracture, a short treatment is as effective as a longer treatment.;Secondary Objective: a) To evaluate the efficacy and safety of different antimicrobials used in IOM. b) To evaluate the development of antimicrobial resistance during antibiotic treatment. c) To evaluate the need for new surgeries during follow-up. d) To provide information about the functional prognosis of the patient according to each of the treatment strategies.;Primary end point(s): Due to clinical failure in the evaluation of TOC. -No disappearance or return to the baseline situation of all clinical criteria present at the beginning. -Not disappearance of all symptoms and signs of infection. -Appearance of new symptoms related to the infection. -Need to suspend the antibiotic or add another due to lack of efficacy based on the above criteria. -Death.;Timepoint(s) of evaluation of this end point: The composited outcome variable "cure" will be used including: a) clinical cure in the test of cure (TOC); b) radiological healing; c) definitive soft tissue coverage at TOC. The TOC will be performed 12 months after the end of antibiotic therapy.	—

Measure

Time frame

Main Objective: To evaluate whether, after performing surgical debridement in patients with IOM due to a large bone fracture, a short treatment is as effective as a longer treatment.;Secondary Objective: a) To evaluate the efficacy and safety of different antimicrobials used in IOM. b) To evaluate the development of antimicrobial resistance during antibiotic treatment. c) To evaluate the need for new surgeries during follow-up. d) To provide information about the functional prognosis of the patient according to each of the treatment strategies.;Primary end point(s): Due to clinical failure in the evaluation of TOC. -No disappearance or return to the baseline situation of all clinical criteria present at the beginning. -Not disappearance of all symptoms and signs of infection. -Appearance of new symptoms related to the infection. -Need to suspend the antibiotic or add another due to lack of efficacy based on the above criteria. -Death.;Timepoint(s) of evaluation of this end point: The composited outcome variable "cure" will be used including: a) clinical cure in the test of cure (TOC); b) radiological healing; c) definitive soft tissue coverage at TOC. The TOC will be performed 12 months after the end of antibiotic therapy.

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Secondary

Measure	Time frame
Secondary end point(s): Adverse events (AE) and severity, resistance development during therapy, secondary infections, recurrence rate, need for new surgeries (debridement, material removal, covering, amputation), and functional status (defined as restoration of limb function prior to fracture).;Timepoint(s) of evaluation of this end point: At the end of the trial	—

Countries

Spain

Contacts

Public ContactUICEC-HUVR

Unidad de Investigación Clínica y ensayos Clínicos

uicec.hvr.sspa@juntadeandalucia.es0034955013414

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026