Antibiotic Use & Open Fracture of the Lower Extremity

NCT05267977 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 041.TRA.2016.D
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Extremity Fracture

Keywords

Gustilo

Outcome Measures

Primary Outcomes (1)

• Aminoglycoside Usage

  The necessity of aminoglycoside usage for patients with open lower extremity fractures.

  Within 24 hours of admission

Secondary Outcomes (6)

• Demographics

  Within 24 hours of admission

• comorbidities

  Within 24 hours of admission

• Total hospital length of stay - HLOS

  Within 24 hours of admission

• deep space infection (DSI)

  Within 24 hours of admission

• grade of fracture

  Within 24 hours of admission

Study Arms (2)

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

Cephalosporin 1St Generation DRUG

cephalosporin; cephalosporin and aminoglycoside

Aminoglycosides DRUG

cephalosporin and aminoglycoside

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Methodist Health System: lead

MeSH Terms

Interventions

First Generation Cephalosporins; Aminoglycosides

Intervention Hierarchy (Ancestors)

beta Lactam Antibiotics; Anti-Bacterial Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Glycosides; Carbohydrates

Study Officials

• Michael S. Truitt, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: March 7, 2022
• Study Start: August 1, 2016
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: March 23, 2026

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)