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New treatment option for Fracture Lower Leg
Official title Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients
ClinicalTrials.gov ID: NCT07561541
What this study is testing
What is Cefadroxil 500 mg Capsules?
Cefadroxil 500 mg Capsules is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for fracture lower leg.
Also referred to as Duricef.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Low extremity fracture requiring surgical treatment
- Uncontrolled diabetes (Hemoglobin A1c \> 7.0 or random glucose \> 200 mg/dL)
- Age 18 years or older
- Able to provide informed consent
- English or Spanish speaker
You likely can't join if
- Known allergy to prescribed antibiotic and pre-determined alternatives
- Open fractures
- Current infection requiring antibiotic treatment
- Immunocompromised status (chemotherapy, immunosuppressant medications)
- End-stage renal disease that medication dosing cannot be adjusted for
- Pregnant or breast-feeding
See the full eligibility criteria
- Low extremity fracture requiring surgical treatment
- Uncontrolled diabetes (Hemoglobin A1c \> 7.0 or random glucose \> 200 mg/dL)
- Age 18 years or older
- Able to provide informed consent
- English or Spanish speaker
- Known allergy to prescribed antibiotic and pre-determined alternatives
- Open fractures
- Current infection requiring antibiotic treatment
- Immunocompromised status (chemotherapy, immunosuppressant medications)
- End-stage renal disease that medication dosing cannot be adjusted for
- Pregnant or breast-feeding
- Unable to comply with follow-up
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- El Paso, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; El Paso, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.