Lower Extremity FracturePhase 3NCT05267977
Antibiotic Use & Open Fracture of the Lower Extremity
A Phase 3 study testing Cephalosporin 1St Generation and Aminoglycosides in people with Lower Extremity Fracture, run by Methodist Health System.
Trial summary
It is important to recognize the potential for renal injury and be cognizant of this during the management of complex trauma patients. The primary aim of this study is to investigate the necessity of aminoglycoside usage for patients with open lower extremity fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Extremity Fracture
- What is being tested?
- Cephalosporin 1St Generation and Aminoglycosides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to 25 May 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients ≥ 18 years of age
- All patients with open grade II or grade III lower extremity open fractures according to the Gustilo Classification of open fracture.
Who cannot join
- Any significant injuries in addition to the lower extremity fracture as determined by the PI that may confound the data.
- Inability to give informed consent or comply with data acquisition (Part 3).
- Pregnant or breast feeding patients due to the potential risks to the mother and/or fetus.
- Prisoners
- Previous bone malignancy
- Bowel or enteric injury at index admission
- TBI of AIS ≥ 5
About this study
It is important to recognize the potential for renal injury and be cognizant of this during the management of complex trauma patients. The primary aim of this study is to investigate the necessity of aminoglycoside usage for patients with open lower extremity fractures. Hypothesis: adding aminoglycoside on top of cephalosporin in treating lower extremity fracture will make no significant difference in term of clinical outcomes when compared to cephalosporin alone.
Read the detailed description
The trauma patient is particularly susceptible to renal injury due to factors such as renal hypoperfusion in the acute setting, the concomitant administration of necessary intravenous contrast agents for diagnostic, and sometimes additionally therapeutic imaging (3). This is additionally complicated by the presentation of trauma patients with pre-existing renal disease.
This study will assess whether prophylactic antibiotics <72hrs have similar outcomes as ≥ 72 hrs of antibiotics, whether type of antibiotics impacts outcomes in patients in either group, help determine the incidence of infection in Gustilo Type III lower extremity fracture when treated either with a single agent (cephalosporin) or dual agent (cephalosporin + aminoglycoside) and the complication profile of patients with Gustilo Type III lower extremity fracture when treated either with a single agent (cephalosporin 1st generation) or dual agent (cephalosporin 1st generation + aminoglycoside).
- Conditions
- Lower Extremity Fracture
- Being tested
- Cephalosporin 1St Generation, Aminoglycosides
- Keywords
- Gustilo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cephalosporin 1St GenerationDrug
AminoglycosidesDrug
| Study group | Role | What they receive |
|---|---|---|
| cephalosporin | Active comparator | cephalosporin Receives: Drug: Cephalosporin 1St Generation |
| cephalosporin and aminoglycoside | Active comparator | the combination of cephalosporin and aminoglycoside. Receives: Drug: Cephalosporin 1St Generation; Drug: Aminoglycosides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aminoglycoside Usage
The necessity of aminoglycoside usage for patients with open lower extremity fractures.
Measured: Within 24 hours of admission
Secondary outcomes (6)
Demographics
age, sex, ethnicity
Measured: Within 24 hours of admission
comorbidities
in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures
Measured: Within 24 hours of admission
Total hospital length of stay - HLOS
in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures
Measured: Within 24 hours of admission
deep space infection (DSI)
in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures
Measured: Within 24 hours of admission
grade of fracture
in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures
Measured: Within 24 hours of admission
surgical site infection (SSI)
in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures
Measured: Within 24 hours of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study startAug 2016
- Primary completion25 May 2022
- Study completion25 May 2022
Why it stopped: Study terminated by PI due to limited resources, no data collected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase: Part 1: Retrospective multi-center study. Part 2: Prospective multi-center study. Number of Sites: Methodist Health System and the associated center. Description of Intervention: Phase 1: No intervention. Phase 2: Patients will be randomized to receive either cephalosporin or the combination of cephalosporin and aminoglycoside. Study Duration: Phase 1: 3 years. Phase 2: 5 years. Subject Participation Duration: Phase 2: Patients will be enrolled in the study until discharge from the hospital. Study participation is strictly voluntary and patient can withdraw at any time.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael S. Truitt, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267977
- Sponsor's protocol ID
- 041.TRA.2016.D
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2019
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Use & Open Fracture of the Lower Extremity
- ClinicalTrials.gov ID
- NCT05267977
- Acronym / sponsor ID
- 041.TRA.2016.D
- Conditions
- Lower Extremity Fracture
- Keywords
- Gustilo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated by PI due to limited resources, no data collected
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is important to recognize the potential for renal injury and be cognizant of this during the management of complex trauma patients. The primary aim of this study is to investigate the necessity of aminoglycoside usage for patients with open lower extremity fractures. Hypothesis: adding aminoglycoside on top of cephalosporin in treating lower extremity fracture will make no significant difference in term of clinical outcomes when compared to cephalosporin alone.
Detailed description
The trauma patient is particularly susceptible to renal injury due to factors such as renal hypoperfusion in the acute setting, the concomitant administration of necessary intravenous contrast agents for diagnostic, and sometimes additionally therapeutic imaging (3). This is additionally complicated by the presentation of trauma patients with pre-existing renal disease.
This study will assess whether prophylactic antibiotics <72hrs have similar outcomes as ≥ 72 hrs of antibiotics, whether type of antibiotics impacts outcomes in patients in either group, help determine the incidence of infection in Gustilo Type III lower extremity fracture when treated either with a single agent (cephalosporin) or dual agent (cephalosporin + aminoglycoside) and the complication profile of patients with Gustilo Type III lower extremity fracture when treated either with a single agent (cephalosporin 1st generation) or dual agent (cephalosporin 1st generation + aminoglycoside).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase: Part 1: Retrospective multi-center study. Part 2: Prospective multi-center study. Number of Sites: Methodist Health System and the associated center. Description of Intervention: Phase 1: No intervention. Phase 2: Patients will be randomized to receive either cephalosporin or the combination of cephalosporin and aminoglycoside. Study Duration: Phase 1: 3 years. Phase 2: 5 years. Subject Participation Duration: Phase 2: Patients will be enrolled in the study until discharge from the hospital. Study participation is strictly voluntary and patient can withdraw at any time.
| Arm | Type | Receives |
|---|---|---|
| cephalosporin | Active comparator | Drug: Cephalosporin 1St Generationcephalosporin |
| cephalosporin and aminoglycoside | Active comparator | Drug: Cephalosporin 1St Generation, Drug: Aminoglycosidesthe combination of cephalosporin and aminoglycoside. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female patients ≥ 18 years of age
- All patients with open grade II or grade III lower extremity open fractures according to the Gustilo Classification of open fracture.
Key exclusion criteria (7 listed)
- Any significant injuries in addition to the lower extremity fracture as determined by the PI that may confound the data.
- Inability to give informed consent or comply with data acquisition (Part 3).
- Pregnant or breast feeding patients due to the potential risks to the mother and/or fetus.
- Prisoners
- Previous bone malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cephalosporin 1St Generation | Drug | cephalosporin, cephalosporin and aminoglycoside |
| Aminoglycosides | Drug | cephalosporin and aminoglycoside |
Primary outcome
Aminoglycoside Usage
Time frame: Within 24 hours of admission
The necessity of aminoglycoside usage for patients with open lower extremity fractures.
6 secondary outcomes
Demographics
Time frame: Within 24 hours of admission
comorbidities
Time frame: Within 24 hours of admission
Total hospital length of stay - HLOS
Time frame: Within 24 hours of admission
deep space infection (DSI)
Time frame: Within 24 hours of admission
grade of fracture
Time frame: Within 24 hours of admission
surgical site infection (SSI)
Time frame: Within 24 hours of admission
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S. Truitt, MD principal investigator
The Methodist Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cephalosporin 1St Generation and Aminoglycosides in people with Lower Extremity Fracture, run by Methodist Health System.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aminoglycoside Usage (time frame: Within 24 hours of admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.