Antibiotics for Diabetes with Bone Fractures

Recruiting at 2 trial locations

Overseen By Taylor M Yong, MD, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Texas Tech University Health Sciences Center, El Paso

Must not be taking: Immunosuppressants

Disqualifiers: Open fractures, Current infection, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 week

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if taking an antibiotic pill for 7 days after surgery reduces the risk of wound infection in adults with poorly controlled diabetes who have surgery to fix a broken bone in the leg, ankle, or foot. It will also learn about the safety of the extended antibiotic course. The main questions it aims to answer are:

Does a 7-day antibiotic course after surgery lower the rate of wound infection within 90 days? What medical problems do participants have when taking the extended antibiotic course?

Researchers will compare a 7-day course of an oral antibiotic (cefadroxil) to standard care (no additional antibiotics after surgery) to see if the extended course reduces infections.

Participants will:

Take an antibiotic pill or receive standard care for 7 days after surgery Receive a phone call from the study team about 1 week after surgery Visit the clinic at 3 weeks, 6 weeks, and 3 months after surgery for checkups

Are You a Good Fit for This Trial?

Inclusion Criteria

Able to provide informed consent

I can speak and understand English or Spanish.

I am 18 years old or older.

Exclusion Criteria

Known allergy to prescribed antibiotic and pre-determined alternatives

I have a broken bone with the fracture exposed through the skin.

I have an infection that needs antibiotics right now.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 7-day course of oral antibiotics or standard care after surgery

1 week

1 phone call about 1 week after surgery

Follow-up

Participants are monitored for surgical site infections and antibiotic-related adverse effects

12 weeks

Clinic visits at 3 weeks, 6 weeks, and 3 months after surgery

What Are the Treatments Tested in This Trial?

Interventions

• Cefadroxil

How Is the Trial Designed?

Group I: Extended oral antibiotic prophylaxis Experimental Treatment 3 Interventions

Extended oral antibiotic therapy in addition to institutional protocols for perioperative antibiotic therapy

Group II: No extended oral antibiotic prophylaxis Active Control 1 Intervention

No additional extended oral antibiotic prophylaxis beyond institutional perioperative protocols.

Who Is Running the Clinical Trial?

Texas Tech University Health Sciences Center, El Paso

Lead Sponsor

Trials

51

Recruited

5,800+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+