Fracture Lower LegPhase 4NCT07561541
Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients
A Phase 4 study testing Cefadroxil 500 mg Capsules, Clindamycin and Bactrim DS in people with Fracture Lower Leg and Diabetes, run by Texas Tech University Health Sciences Center, El Paso at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture Lower Leg, Diabetes, Fracture Fixation, Internal
- What is being tested?
- Cefadroxil 500 mg Capsules, Clindamycin and Bactrim DS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2026to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University Medical Center of El Paso
El Paso, Texas, 79905
Taylor Yong, 8322027406, tayong@ttuhsc.edu
- Recruiting
Texas Tech Health El Paso
El Paso, Texas, 79912
Taylor M Yong, MD, MS, 915-215-5480, tayong@ttuhsc.edu
- Recruiting
University of Southern California
Los Angeles, California, 90033
Sarah Blumenthal, MD, 800-872-2273, Sarah.Blumenthal@med.usc.edu
About this study
Official title: Extended Oral Antibiotic Prophylaxis in Diabetic Patients With Lower Extremity Fracture: A Multicenter Pilot Randomized Controlled 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?
Read more
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
Read the detailed description
The purpose of this research study is to investigate whether a 7-day course of an oral, prophylactic antibiotic following surgical fixation of a lower extremity fracture effectively decreases the risk of surgical site infection in patients with poorly controlled diabetes. Patients with an uncontrolled hemoglobin A1c greater than 7.0 or a random blood glucose greater than 200 mg/dL undergoing operative fixation of a closed fracture of the distal femur, patella, tibial plateau, tibial shaft, pilon, ankle, talus, calcaneus, or other operative foot fracture are considered high-risk for surgical site infection and are the target population for this study.
Study participants will be randomized to either a 7-day course of an oral prophylactic antibiotic following surgery (cefadroxil 500 mg twice daily, or an alternative regimen based on allergy status or methicillin-resistant Staphylococcus aureus colonization) or standard care with no additional antibiotics beyond the standard perioperative intravenous antibiotic dosing. All other standard perioperative fracture care will remain the same for both groups. Outcomes assessed will include superficial and deep surgical site infection occurring within 90 days of surgery, antibiotic-related adverse effects, and patient compliance with the extended antibiotic regimen.
- Conditions
- Fracture Lower Leg, Diabetes, Fracture Fixation, Internal
- Being tested
- Cefadroxil 500 mg Capsules, Clindamycin, Bactrim DS
- Keywords
- Diabetes, Lower extremity fracture, Extended oral antibiotic prophylaxis
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefadroxil 500 mg CapsulesDrug
Also called Duricef
Cefadroxil 500 mg, twice a day for 7 days
ClindamycinDrug
Clindamycin 300 mg, three times a day for 7 days
Bactrim DSDrug
Bactrim DS, twice a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| No extended oral antibiotic prophylaxis | No intervention | No additional extended oral antibiotic prophylaxis beyond institutional perioperative protocols. |
| Extended oral antibiotic prophylaxis | Experimental | Extended oral antibiotic therapy in addition to institutional protocols for perioperative antibiotic therapy Receives: Drug: Cefadroxil 500 mg Capsules; Drug: Clindamycin; Drug: Bactrim DS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Incidence of superficial infection (a wound with erythema, warmth, or drainage that is treated with oral antibiotics or wound care) and deep infection (per fracture-related infection definition).
Measured: 90 days
Secondary outcomes (2)
Antibiotic-related adverse effects
Incidence of antibiotic-related adverse effects
Measured: 90 days
Compliance with antibiotic regimen
Number of patients completing prescribed antibiotic regimen or not
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fracture Lower LegStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California
- Responsible party
- Principal investigator, Taylor M. Yong, Texas Tech University Health Sciences Center, El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561541
- Sponsor's protocol ID
- E26052
- Other IDs
- 4983
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lipson S, Pagani NR, Moverman MA, Puzzitiello RN, Menendez ME, Smith EL. The Cost-Effectiveness of Extended Oral Antibiotic Prophylaxis for Infection Prevention After Total Joint Arthroplasty in High-Risk Patients. J Arthroplasty. 2022 Oct;37(10):1961-1966. doi: 10.1016/j.arth.2022.04.025. Epub 2022 Apr 25.
PubMed 35472436Dasari SP, Kanumuri SD, Yang J, Manner PA, Fernando ND, Hernandez NM. Extended Prophylactic Antibiotics for Primary and Aseptic Revision Total Joint Arthroplasty: A Meta-Analysis. J Arthroplasty. 2024 Sep;39(9 Suppl 2):S476-S487. doi: 10.1016/j.arth.2024.01.014. Epub 2024 Jan 17.
PubMed 38237874Inabathula A, Dilley JE, Ziemba-Davis M, Warth LC, Azzam KA, Ireland PH, Meneghini RM. Extended Oral Antibiotic Prophylaxis in High-Risk Patients Substantially Reduces Primary Total Hip and Knee Arthroplasty 90-Day Infection Rate. J Bone Joint Surg Am. 2018 Dec 19;100(24):2103-2109. doi: 10.2106/JBJS.17.01485.
PubMed 30562290Kheir MM, Dilley JE, Ziemba-Davis M, Meneghini RM. The AAHKS Clinical Research Award: Extended Oral Antibiotics Prevent Periprosthetic Joint Infection in High-Risk Cases: 3855 Patients With 1-Year Follow-Up. J Arthroplasty. 2021 Jul;36(7S):S18-S25. doi: 10.1016/j.arth.2021.01.051. Epub 2021 Jan 23.
PubMed 33589279
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Oral Antibiotic Prophylaxis in Diabetic Patients With Lower Extremity Fracture: A Multicenter Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07561541
- Acronym / sponsor ID
- E26052
- Conditions
- Fracture Lower Leg, Diabetes, Fracture Fixation, Internal
- Keywords
- Diabetes, Lower extremity fracture, Extended oral antibiotic prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Collaborators
- University of Southern California
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 May 2026 (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.
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
Detailed description
The purpose of this research study is to investigate whether a 7-day course of an oral, prophylactic antibiotic following surgical fixation of a lower extremity fracture effectively decreases the risk of surgical site infection in patients with poorly controlled diabetes. Patients with an uncontrolled hemoglobin A1c greater than 7.0 or a random blood glucose greater than 200 mg/dL undergoing operative fixation of a closed fracture of the distal femur, patella, tibial plateau, tibial shaft, pilon, ankle, talus, calcaneus, or other operative foot fracture are considered high-risk for surgical site infection and are the target population for this study.
Study participants will be randomized to either a 7-day course of an oral prophylactic antibiotic following surgery (cefadroxil 500 mg twice daily, or an alternative regimen based on allergy status or methicillin-resistant Staphylococcus aureus colonization) or standard care with no additional antibiotics beyond the standard perioperative intravenous antibiotic dosing. All other standard perioperative fracture care will remain the same for both groups. Outcomes assessed will include superficial and deep surgical site infection occurring within 90 days of surgery, antibiotic-related adverse effects, and patient compliance with the extended antibiotic regimen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No extended oral antibiotic prophylaxis | No intervention | –No additional extended oral antibiotic prophylaxis beyond institutional perioperative protocols. |
| Extended oral antibiotic prophylaxis | Experimental | Drug: Cefadroxil 500 mg Capsules, Drug: Clindamycin, Drug: Bactrim DSExtended oral antibiotic therapy in addition to institutional protocols for perioperative antibiotic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Cefadroxil 500 mg CapsulesAlso: DuricefCefadroxil 500 mg, twice a day for 7 days | Drug | Extended oral antibiotic prophylaxis |
| ClindamycinClindamycin 300 mg, three times a day for 7 days | Drug | Extended oral antibiotic prophylaxis |
| Bactrim DSBactrim DS, twice a day for 7 days | Drug | Extended oral antibiotic prophylaxis |
Primary outcome
Surgical site infection
Time frame: 90 days
Incidence of superficial infection (a wound with erythema, warmth, or drainage that is treated with oral antibiotics or wound care) and deep infection (per fracture-related infection definition).
2 secondary outcomes
Antibiotic-related adverse effects
Time frame: 90 days
Compliance with antibiotic regimen
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 35472436Lipson S, Pagani NR, Moverman MA, Puzzitiello RN, Menendez ME, Smith EL. The Cost-Effectiveness of Extended Oral Antibiotic Prophylaxis for Infection Prevention After Total Joint Arthroplasty in High-Risk Patients. J Arthroplasty. 2022 Oct;37(10):1961-1966. doi: 10.1016/j.arth.2022.04.025. Epub 2022 Apr 25.
- Background: PubMed 38237874Dasari SP, Kanumuri SD, Yang J, Manner PA, Fernando ND, Hernandez NM. Extended Prophylactic Antibiotics for Primary and Aseptic Revision Total Joint Arthroplasty: A Meta-Analysis. J Arthroplasty. 2024 Sep;39(9 Suppl 2):S476-S487. doi: 10.1016/j.arth.2024.01.014. Epub 2024 Jan 17.
- Background: PubMed 30562290Inabathula A, Dilley JE, Ziemba-Davis M, Warth LC, Azzam KA, Ireland PH, Meneghini RM. Extended Oral Antibiotic Prophylaxis in High-Risk Patients Substantially Reduces Primary Total Hip and Knee Arthroplasty 90-Day Infection Rate. J Bone Joint Surg Am. 2018 Dec 19;100(24):2103-2109. doi: 10.2106/JBJS.17.01485.
- Background: PubMed 33589279Kheir MM, Dilley JE, Ziemba-Davis M, Meneghini RM. The AAHKS Clinical Research Award: Extended Oral Antibiotics Prevent Periprosthetic Joint Infection in High-Risk Cases: 3855 Patients With 1-Year Follow-Up. J Arthroplasty. 2021 Jul;36(7S):S18-S25. doi: 10.1016/j.arth.2021.01.051. Epub 2021 Jan 23.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefadroxil 500 mg Capsules, Clindamycin and Bactrim DS in people with Fracture Lower Leg and Diabetes, run by Texas Tech University Health Sciences Center, El Paso at 3 sites in United States.
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 5 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: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taylor M Yong, MD, MS (915-215-5480, tayong@ttuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07561541, which also lists 4 linked publications.
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 8 May 2026.