[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07561541":3,"trial-entities:NCT07561541":138,"trial-summary:NCT07561541":143},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":48,"secondary_outcomes":53,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":80,"locations":83,"central_contacts":120,"overall_officials":122,"references":123,"see_also_links":137},"NCT07561541","E26052","Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients","Extended Oral Antibiotic Prophylaxis in Diabetic Patients With Lower Extremity Fracture: A Multicenter Pilot Randomized Controlled Trial","RECRUITING","2027-12-31","2026-05","2026-05-08","2026-04-01","Texas Tech University Health Sciences Center, El Paso","OTHER",false,"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:\n\nDoes 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?\n\nResearchers 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.\n\nParticipants will:\n\nTake 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","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\u002FdL 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.\n\nStudy 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.",[19,20,21],"Fracture Lower Leg","Diabetes","Fracture Fixation, Internal",[20,23,24],"Lower extremity fracture","Extended oral antibiotic prophylaxis","INTERVENTIONAL","PREVENTION",[28],"PHASE4",{"count":30,"type":31},40,"ESTIMATED",[33,40,44],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Cefadroxil 500 mg Capsules","Cefadroxil 500 mg, twice a day for 7 days",[24],[39],"Duricef",{"type":34,"name":41,"description":42,"armGroupLabels":43},"Clindamycin","Clindamycin 300 mg, three times a day for 7 days",[24],{"type":34,"name":45,"description":46,"armGroupLabels":47},"Bactrim DS","Bactrim DS, twice a day for 7 days",[24],[49],{"measure":50,"description":51,"timeFrame":52},"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).","90 days",[54,57],{"measure":55,"description":56,"timeFrame":52},"Antibiotic-related adverse effects","Incidence of antibiotic-related adverse effects",{"measure":58,"description":59,"timeFrame":60},"Compliance with antibiotic regimen","Number of patients completing prescribed antibiotic regimen or not","1 week","ALL","18 Years",null,{"inclusion":65,"exclusion":71,"raw_text":79},[66,67,68,69,70],"Low extremity fracture requiring surgical treatment","Uncontrolled diabetes (Hemoglobin A1c \\> 7.0 or random glucose \\> 200 mg\u002FdL)","Age 18 years or older","Able to provide informed consent","English or Spanish speaker",[72,73,74,75,76,77,78],"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","Inclusion Criteria:\n\n* Low extremity fracture requiring surgical treatment\n* Uncontrolled diabetes (Hemoglobin A1c \\> 7.0 or random glucose \\> 200 mg\u002FdL)\n* Age 18 years or older\n* Able to provide informed consent\n* English or Spanish speaker\n\nExclusion Criteria:\n\n* Known allergy to prescribed antibiotic and pre-determined alternatives\n* Open fractures\n* Current infection requiring antibiotic treatment\n* Immunocompromised status (chemotherapy, immunosuppressant medications)\n* End-stage renal disease that medication dosing cannot be adjusted for\n* Pregnant or breast-feeding\n* Unable to comply with follow-up",[81,82],"ADULT","OLDER_ADULT",[84,99,112],{"facility":85,"status":8,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":96},"University of Southern California","Los Angeles","California","90033","United States",[91],{"name":92,"role":93,"phone":94,"email":95},"Sarah Blumenthal, MD","CONTACT","800-872-2273","Sarah.Blumenthal@med.usc.edu",{"lat":97,"lon":98},34.05223,-118.24368,{"facility":100,"status":8,"city":101,"state":102,"zip":103,"country":89,"contacts":104,"geoPoint":109},"University Medical Center of El Paso","El Paso","Texas","79905",[105],{"name":106,"role":93,"phone":107,"email":108},"Taylor Yong","8322027406","tayong@ttuhsc.edu",{"lat":110,"lon":111},31.75872,-106.48693,{"facility":113,"status":8,"city":101,"state":102,"zip":114,"country":89,"contacts":115,"geoPoint":119},"Texas Tech Health El Paso","79912",[116],{"name":117,"role":93,"phone":118,"email":108},"Taylor M Yong, MD, MS","915-215-5480",{"lat":110,"lon":111},[121],{"name":117,"role":93,"phone":118,"email":108},[],[124,128,131,134],{"pmid":125,"type":126,"citation":127},"35472436","BACKGROUND","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\u002Fj.arth.2022.04.025. Epub 2022 Apr 25.",{"pmid":129,"type":126,"citation":130},"38237874","Dasari 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\u002Fj.arth.2024.01.014. Epub 2024 Jan 17.",{"pmid":132,"type":126,"citation":133},"30562290","Inabathula 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\u002FJBJS.17.01485.",{"pmid":135,"type":126,"citation":136},"33589279","Kheir 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\u002Fj.arth.2021.01.051. Epub 2021 Jan 23.",[],{"nct_id":4,"conditions":139,"biomarkers":142},[140,141],"Diabetes Mellitus","Lower Extremity Fracture",[],{"nct_id":4,"found":144,"summary":145,"prompt_version":155},true,{"design":146,"status":147,"heading":148,"summary":149,"follow_up":150,"word_count":151,"commitments":152,"compensation":153,"drugs_mentioned":154},"This interventional study plans to enroll 40 participants. It will compare a 7-day course of an oral antibiotic to standard care.","completed","Extended Oral Antibiotics for Diabetic Fracture Patients","This study is looking into whether taking an antibiotic pill for 7 days after surgery can lower the chance of wound infection in adults with poorly controlled diabetes who have a broken bone in their leg, ankle, or foot. You might be eligible if you are 18 or older, have a lower leg fracture needing surgery, and have uncontrolled diabetes (Hemoglobin A1c greater than 7.0 or random glucose greater than 200 mg\u002FdL). Researchers will compare a 7-day course of Cefadroxil 500 mg (or Clindamycin or Bactrim DS if needed) to standard care (no extra antibiotics after surgery). The main goal is to see if this extended antibiotic course reduces surgical site infections within 90 days and what side effects might occur. The study aims to enroll 40 participants, but its current status is unclear.","Participants will be followed for surgical site infection for 90 days after surgery.",134,"Not specified in the trial record.","Not stated in the trial record.",[41,45],"v2"]