Antibiotic Use & Open Fracture of the Lower Extremity | NCT05267977

Studies
Antibiotic Use & Open Fracture of the Lower Extremity

NCT05267977

Sponsor

Methodist Health System

Status

Withdrawn

Last Update Posted

Mar 23, 2026Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Lower Extremity Fracture

Interventions

Cephalosporin 1St Generation
Aminoglycosides

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study terminated by PI due to limited resources, no data collected

Expanded Access Info

Start Date

Aug 2016Actual

Primary Completion Date

May 25, 2022Actual

Completion Date

May 25, 2022Actual

First Submitted Date

Aug 12, 2019

First Submission Date that Met QC Criteria

Mar 1, 2022

First Posted Date

Mar 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2026

Last Update Posted Date

Mar 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cephalosporin	Active Comparator	cephalosporin	Drug: Cephalosporin 1St Generation
cephalosporin and aminoglycoside	Active Comparator	the combination of cephalosporin and aminoglycoside.	Drug: Cephalosporin 1St Generation Drug: Aminoglycosides

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cephalosporin 1St Generation	Drug		cephalosporin cephalosporin and aminoglycoside
Aminoglycosides

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Aminoglycoside Usage	The necessity of aminoglycoside usage for patients with open lower extremity fractures.	Within 24 hours of admission

Secondary Outcomes

Measure	Description	Time Frame
Demographics	age, sex, ethnicity	Within 24 hours of admission
comorbidities	in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael S. Truitt, MD	The Methodist Hospital Research Institute	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000097904	First Generation Cephalosporins
D000617	Aminoglycosides

Ancestor Terms

ID	Term
D000097902	beta Lactam Antibiotics
D000900	Anti-Bacterial Agents
D000890	Anti-Infective Agents
D045506	Therapeutic Uses

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.