Clinical Trials

Numerous clinical trials, spanning Early Phase 1 through Phase 4, evaluate cefazolin sodium for perioperative antibiotic prophylaxis and surgical site infection prevention across diverse settings, including bariatric, cesarean, and pediatric surgeries. Sponsored by academic institutions such as Northwestern University and the University of California, Los Angeles, these studies encompass various recruitment statuses—including completed, active, recruiting, and withdrawn—reflecting extensive evaluation into mitigating surgical and wound-related bacterial infections.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06055712 ENROLLING_BY_INVITATION
Fractures, Open; Infections
St. Louis University
 2023-09-11 PHASE4
NCT06640491 RECRUITING
Total Knee Arthroplasty
The Methodist Hospital Research Institute
 2025-05-15 PHASE1; PHASE2
NCT05137119 RECRUITING
Staphylococcus Aureus Bacteremia
University of Melbourne
 2022-02-16 PHASE4
NCT06406114 RECRUITING
Drug Allergy; Cephalosporin Allergy; Drug Hypersensitivity; Antibiotic Allergy; Beta Lactam Adverse Reaction; Drug-Induced Anaphylaxis; Cephalosporin Reaction
Massachusetts General Hospital
 2025-05-05 PHASE2
NCT07608562 NOT_YET_RECRUITING
Cervical Insufficiency
Wake Forest University Health Sciences
 2026-09 PHASE4
NCT06567808 NOT_YET_RECRUITING
Infection, Surgical Site
Hamilton Health Sciences Corporation
 2026-03-01 PHASE4
NCT05447559 RECRUITING
Surgical Site Infection
Monash University
 2023-02-07 PHASE4
NCT06327113 RECRUITING
Non-healing Wound
University of California, Los Angeles
 2024-05-17 PHASE2
NCT04886284 RECRUITING
Staphylococcus Aureus Bacteremia; Staphylococcus Aureus Septicemia; Staphylococcal Sepsis; Staphylococcus Aureus Endocarditis
Todd C. Lee MD MPH FIDSA
 2024-05-20 PHASE2
NCT06920147 NOT_YET_RECRUITING
Surgical Site Infection
The University of Texas Health Science Center, Houston
 2025-05-01 PHASE4
NCT05304871 WITHDRAWN
Vascular Access Ports
Dartmouth-Hitchcock Medical Center
 2024-01
NCT04875728 ACTIVE_NOT_RECRUITING
Clinical Stage I Cutaneous Melanoma AJCC v8; Clinical Stage IA Cutaneous Melanoma AJCC v8; Clinical Stage IB Cutaneous Melanoma AJCC v8; Clinical Stage II Cutaneous Melanoma AJCC v8; Clinical Stage IIA Cutaneous Melanoma AJCC v8; Clinical Stage IIB Cutaneous Melanoma AJCC v8; Clinical Stage IIC Cutaneous Melanoma AJCC v8; Pathologic Stage I Cutaneous Melanoma AJCC v8; Pathologic Stage IA Cutaneous Melanoma AJCC v8; Pathologic Stage IB Cutaneous Melanoma AJCC v8; Pathologic Stage II Cutaneous Melanoma AJCC v8; Pathologic Stage IIA Cutaneous Melanoma AJCC v8; Pathologic Stage IIB Cutaneous Melanoma AJCC v8; Pathologic Stage IIC Cutaneous Melanoma AJCC v8
M.D. Anderson Cancer Center
 2020-09-08 PHASE1
NCT05852158 RECRUITING
Orthognathic Surgical Site Infection
Abdul El-Rabbany
 2024-01-09 PHASE4
NCT04538053 RECRUITING
Bone Infection; Septic Arthritis; Bone and Joint Infection; Osteomyelitis
Murdoch Childrens Research Institute
 2021-06-01 PHASE4
NCT02996656 RECRUITING
Propionibacterium Infection
Université de Montréal
 2016-12
NCT07549542 ENROLLING_BY_INVITATION
Antibiotic Prophylaxis Surgery
Rutgers, The State University of New Jersey
 2025-10-20 PHASE4
NCT07655596 NOT_YET_RECRUITING
Surgical Site Infection (SSI)
Helwan University
 2026-07-01 PHASE4
NCT07658378 NOT_YET_RECRUITING
Surgical Site Infection (SSI)
Helwan University
 2026-07-01 PHASE4
NCT04731025 ACTIVE_NOT_RECRUITING
Implant Complication; Implant Infection; Implant Site Infection; Implant Capsular Contracture; Implant Site Pocket Infection; Implant Expulsion; Antibiotic Side Effect
Mikkel Herly
 2021-01-27 PHASE3
NCT07067736 RECRUITING
Hydrocephaly; CSF Shunts; Antibiotic Prophylaxis
University Hospital, Strasbourg, France
 2026-02-01
NCT06189885 UNKNOWN
Periprosthetic Joint Infection
Chang Gung Memorial Hospital
 2024-08-01
NCT06426836 RECRUITING
Pharmacokinetics; Amoxicillin-clavulanate; Piperacillin-tazobactam; Meropenem; Cefazolin; Teicoplanin; Vancomycin; Ciprofloxacin; Amikacin
University Hospital, Ghent
 2016-08-19
NCT05199324 COMPLETED
Gram-negative Bacteraemia
Tan Tock Seng Hospital
 2022-06-03 PHASE4
NCT07327502 NOT_YET_RECRUITING
Children in Cardiac Intensive Care Requiring Surgery for Congenital Heart Disease
Assistance Publique - Hôpitaux de Paris
 2026-01
NCT05604157 UNKNOWN
Infections Joint Prosthetic
McGill University Health Centre/Research Institute of the McGill University Health Centre
 2021-09-16
NCT07478874 COMPLETED
Surgical Site Infection (SSI)
Lahore General Hospital
 2025-07-01
NCT06510452 UNKNOWN
Antibiotic Reaction; Wound Infection Superficial; Wound Infection Deep; Bariatric Surgery Candidate; Complication,Postoperative
General Committee of Teaching Hospitals and Institutes, Egypt
 2024-10-01
NCT06093269 ACTIVE_NOT_RECRUITING
Hemodialysis Catheter Infection; Infection, Bacterial
University Hospital, Tours
 2023-11-20 PHASE4
NCT05655091 RECRUITING
Complicated Staphylococcus Aureus (S. Aureus) Infections (CSAI)
University Hospital, Basel, Switzerland
 2023-10-26 PHASE2
NCT06005168 COMPLETED
Surgical Prophylaxis
University of Michigan
 2023-03-08 PHASE4
NCT06576154 UNKNOWN
Antibiotic Prophylaxis; Wound Infection; Groin Hernia
University of Aleppo
 2024-08-01 PHASE3
NCT06336824 UNKNOWN
Staphylococcus Aureus Bacteremia
Clinical Research Centre, Malaysia
 2024-06-28 PHASE3
NCT02285140 TERMINATED
Thoracic Surgery; Antibiotic Prophylaxis
Hamilton Health Sciences Corporation
 2015-04
NCT05977868 TERMINATED
Endovascular Infection; Bone and Joint Infection; Skin and Soft Tissue Infection; Pulmonary Infection; Gastrointestinal Infection; Genitourinary Infection
West Virginia University
 2023-08-04 PHASE4
NCT05132829 UNKNOWN
Preterm Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Physiological Effects of Drugs; Uterine Cervical Incompetence; Anti-Bacterial Agents; Azithromycin; Cefazolin
Thomas Jefferson University
 2021-12-20 PHASE4
NCT03283878 COMPLETED
Arthropathy of Knee; Antibiotic Prophylaxis
Duke University
 2017-10-24 PHASE4
NCT06710977 COMPLETED
Cataract
Tan Tock Seng Hospital
 2022-01-01 EARLY_PHASE1
NCT06355115 UNKNOWN
Pacemaker Complication
University of Brawijaya
 2023-09-01 PHASE2
NCT07111702 COMPLETED
Surgical Site Infection; Groin Hernia; Hernioplasty
Sana'a University
 2023-10-01
NCT04834310 WITHDRAWN
Surgical Site Infection; Capsular Contracture Associated With Breast Implant; Antibiotic Resistant Infection; Antibiotic Side Effect
University of California, Los Angeles
 2021-04-01 PHASE4
NCT03248063 COMPLETED
Bacteremia Due to Methicillin Susceptible Staphylococcus Aureus
Assistance Publique - Hôpitaux de Paris
 2018-09-05
NCT03593252 UNKNOWN
Colostomy; Hirschsprung Disease - Pull Through; Necrotizing Enterocolitis; Inflammatory Bowel Diseases; Meconium Ileus; Bowel Obstruction; Elective Surgery
McMaster University
 2022-01-01
NCT03046511 UNKNOWN
Peritoneal Dialysis-associated Peritonitis; Peritoneal Dialysis Catheter Infection; Peritoneal Dialysis Complication
Carmel Medical Center
 2017-03-08 PHASE3
NCT06402591 UNKNOWN
Infection Prosthesis Hip and Knee; Infection, Prosthesis Related; Joint Infection; Infection, Surgical Site; Surgical Site Infection; Infection Pro
Radboud University Medical Center
 2019-01-01 PHASE3
NCT05647993 COMPLETED
Febrile Morbidity After Emergency Cesarean Section
Department of Medical Services Ministry of Public Health of Thailand
 2022-12-14
NCT04775953 COMPLETED
Staphylococcal Bacteraemia
National Institute of Allergy and Infectious Diseases (NIAID)
 2021-04-22 PHASE2
NCT04288206 UNKNOWN
Supracondylar Humerus Fracture; Infection
Legacy Health System
 2021-01-07
NCT05421312 UNKNOWN
PJI; Bone and Joint Infection; Pharmacokinetics
Radboud University Medical Center
 2022-09 PHASE4
NCT05205486 COMPLETED
Infections
B. Braun Medical Inc.
 2022-04-05 PHASE1
NCT04141787 UNKNOWN
Staphylococcal Infections; Osteomyelitis; CNS Infection; Septic Arthritis; Diabetic Foot Infection; Vertebral Osteomyelitis; Abscess; Coagulase Negative Staphylococcal Infection
Vancouver Island Health Authority
 2019-07-11 PHASE4
NCT03402945 COMPLETED
Surgical Site Infections
Population Health Research Institute
 2018-03-05 PHASE4
NCT03261830 COMPLETED
Supracondylar Humerus Fracture; Post Operative Wound Infection
Sumit Gupta
 2017-08-18 PHASE4
NCT03672149 UNKNOWN
Renal Replacement Therapy; Pharmacokinetics
Drexel University
 2019-07-18 PHASE1
NCT06030713 COMPLETED
Microbial Colonization; Antibiotic Side Effect; Cesarean Section Complications
University Medical Center Groningen
 2019-03-01
NCT05309304 COMPLETED
Healthy
Baxter Healthcare Corporation
 2022-02-14 PHASE1
NCT03190668 COMPLETED
Idiopathic Scoliosis
University of Florida
 2018-05-29 PHASE4
NCT04303390 COMPLETED
Surgical Site Infection
Saud Al Babtain Cardiac Center
 2018-02-06 PHASE4
NCT04763486 UNKNOWN
Puerperal Infection
Meir Medical Center
 2021-03-01
NCT03578965 COMPLETED
Premalignant Vulvar Lesion; Benign Vulvar Lesion
Washington University School of Medicine
 2018-07-13 PHASE2
NCT03742908 UNKNOWN
Breast Neoplasms
Tianjin Medical University Cancer Institute and Hospital
 2018-06-16
NCT03801252 COMPLETED
Obesity; Induction of Labor Affected Fetus / Newborn
University of Oklahoma
 2018-12-12 EARLY_PHASE1
NCT03478163 TERMINATED
Obstetric Complication; Postpartum Hemorrhage; Postpartum Endometritis
Cedars-Sinai Medical Center
 2018-03-08 PHASE4
NCT01479283 COMPLETED
Infection; Bone Neoplasms
McMaster University
 2013-01 PHASE3
NCT02216227 COMPLETED
Surgical Site Infection
VA Office of Research and Development
 2014-04-01
NCT03432858 COMPLETED
Carpal Tunnel Syndrome
WellSpan Health
 2018-05-17 PHASE4
NCT01503606 COMPLETED
Preterm Premature Rupture of Membrane
Samsung Medical Center
 2011-10 PHASE3
NCT04516148 COMPLETED
Burn; Surgery; Infection Wound
Medstar Health Research Institute
 2018-05-29 PHASE4
NCT02717871 COMPLETED
Keratitis; Infectious Disease (Manifestation)
University Hospital, Geneva
 2016-03 PHASE3
NCT03853096 UNKNOWN
Surgical Site Infection; Microbial Colonization
University of British Columbia
 2019-04-01 EARLY_PHASE1
NCT01792804 COMPLETED
Staphylococcus Aureus Infection
Heinrich-Heine University, Duesseldorf
 2013-12 PHASE3
NCT02800785 COMPLETED
Appendicitis
University of Washington
 2016-05
NCT03560232 TERMINATED
Open Fracture; Post-Op Wound Infection
Mercy Health Ohio
 2018-07-09 PHASE4
NCT03862170 TERMINATED
Prostate Cancer
CR-CSSS Champlain-Charles-Le Moyne
 2015-02-10 PHASE3
NCT03675854 WITHDRAWN
Peritoneal Dialysis-associated Peritonitis
Chinese University of Hong Kong
 2019-01-01 PHASE4
NCT02838940 UNKNOWN
Blood Antibiotic Levels
Tel-Aviv Sourasky Medical Center
 2016-08 PHASE3
NCT03231228 TERMINATED
Postoperative Infection
B. Braun Medical Inc.
 2017-11-20 PHASE4
NCT04818931 COMPLETED
Breast Cancer
CHU de Quebec-Universite Laval
 2018-04-07
NCT02503904 UNKNOWN
Surgical Site Infections; Venous Thromboembolism
Klein, Jeffrey A., M.D.
 2015-10 PHASE2; PHASE3
NCT02497365 COMPLETED
Bacterial Keratitis
McGill University Health Centre/Research Institute of the McGill University Health Centre
 2015-09
NCT03466645 UNKNOWN
Elective Craniotomy-candidated Patients
Isfahan University of Medical Sciences
 2018-04-01 PHASE1; PHASE2
NCT02666365 WITHDRAWN
Surgical Site Infections
Milton S. Hershey Medical Center
 2018-03 PHASE4
NCT02593201 COMPLETED
Peritoneal Dialysis
Chinese University of Hong Kong
 2016-02-26 PHASE4
NCT01886742 WITHDRAWN
Obesity
University of Colorado, Denver
 2017-09-01 PHASE4
NCT02344511 WITHDRAWN
Osteomyelitis
Durata Therapeutics International BV (an Affiliate of Actavis, Inc.)
 2016-03 PHASE3
NCT03213249 COMPLETED
Breast Implant Infection; Mammoplasty
Washington University School of Medicine
 2017-07-25 PHASE1
NCT03595852 COMPLETED
Surgical Site Infection
University of Rwanda
 2018-03-01
NCT00850122 COMPLETED
Sepsis; Prematurity
Phillip Brian Smith
 2013-07 PHASE1
NCT03502356 UNKNOWN
Randomized Controll Trial
Ain Shams University
 2018-04-20 PHASE1; PHASE2
NCT03094663 COMPLETED
Knee Arthropathy
Hospital for Special Surgery, New York
 2017-02-28 PHASE4
NCT02208063 TERMINATED
Bacteremia
Cumberland Pharmaceuticals
 2014-12 PHASE3
NCT02534961 UNKNOWN
Hepatocellular Carcinoma
Taipei Veterans General Hospital, Taiwan
 2015-01 PHASE4
NCT02584426 COMPLETED
Spinal Cord Injury; Chronic Pressure Ulcers
James J. Peters Veterans Affairs Medical Center
 2017-01
NCT01980082 COMPLETED
Surgical Wound Infection
Rabin Medical Center
 2014-01 PHASE4
NCT02433704 WITHDRAWN
Acute Infection of Total Knee Replacement
Duke University
 2015-05 PHASE4
NCT02809729 COMPLETED
Breast Neoplasms; Breast-Conserving Surgery; Wound Infection; Antibiotic Prophylaxis
Fabiola Soares Moreira Campos
 2015-01
NCT03115177 COMPLETED
Osteoarthritis
Rush University Medical Center
 2015-11
NCT02307006 UNKNOWN
Surgical Site Infection
University of Cincinnati
 2015-01 PHASE4
NCT02872038 COMPLETED
Peritoneal Dialysis Associated Peritonitis
Chulalongkorn University
 2015-08 PHASE4
NCT02292082 COMPLETED
Osteoarthritis
Hospital for Special Surgery, New York
 2014-11 PHASE4
NCT02058979 COMPLETED
Plasma Concentration of Antibiotics
University of Virginia
 2014-11
NCT02446782 COMPLETED
Pleural Effusion; Pleurisy; Empyema
Post Graduate Institute of Medical Education and Research, Chandigarh
 2015-01 PHASE4
NCT02324166 UNKNOWN
Vitreoretinal Surgery; Endophthalmitis
University Health Network, Toronto
 2015-01 PHASE4
NCT02368015 COMPLETED
Hepatic Cyst
Radboud University Medical Center
 2014-12
NCT01823523 UNKNOWN
Dentofacial Deformity
Atlantic Center for Oral and Maxillofacial Surgery
 2013-06
NCT02027532 TERMINATED
Infection; Closed Fractures
University of Tennessee
 2009-10
NCT02493894 COMPLETED
Surgery
Isfahan University of Medical Sciences
 2014-07 PHASE1; PHASE2
NCT01537380 COMPLETED
Bariatric Surgery
Nantes University Hospital
 2012-03 PHASE4
NCT01991834 COMPLETED
Infection Secondary to Surgical Procedure
Universidade do Vale do Sapucai
 2013-09
NCT02413034 COMPLETED
Prosthetic Joint Infection
Parc de Salut Mar
 2013-11
NCT01619982 COMPLETED
Congenital Heart Diseases; Aortic Valve Disorder
Stanford University
 2012-02 PHASE4
NCT01721616 WITHDRAWN
Endometritis
University of Missouri, Kansas City
 2012-11 PHASE4
NCT01029782 COMPLETED
Cellulitis
Kelowna General Hospital
 2010-05 PHASE2
NCT02049944 COMPLETED
Obesity; Obesity, Morbid; Pregnancy; Infection; Cesarean Section
MemorialCare Health System
 2013-08 PHASE4
NCT01810354 COMPLETED
Infection Prevention
Women and Infants Hospital of Rhode Island
 2013-04
NCT01400867 COMPLETED
Infections, Pediatrics
Forest Laboratories
 2011-12 PHASE2; PHASE3
NCT01904500 COMPLETED
Obesity; Pregnancy
University of Pittsburgh
 2013-08 PHASE1
NCT00610987 COMPLETED
Fractures, Closed; Wounds and Injuries
University of Missouri-Columbia
 2008-01
NCT01785641 COMPLETED
Peritonitis
Chulalongkorn University
 2012-12
NCT01993134 UNKNOWN
Facial Fractures
Universidade Federal do Rio Grande do Norte
 2011-12 PHASE2
NCT01613092 COMPLETED
Arrhythmia
Population Health Research Institute
 2011-05 PHASE4
NCT01904357 COMPLETED
Infections
B. Braun Medical Inc.
 2013-03 PHASE1
NCT01880112 WITHDRAWN
Infection; Cesarean Delivery; Antibiotic Prophylaxis
West Virginia University
 2011-06 PHASE4
NCT01612052 UNKNOWN
MRSA - Methicillin Resistant Staphylococcus Aureus Infection
CAMC Health System
 2011-05 PHASE4
NCT01114516 COMPLETED
Cervical Insufficiency
Northwestern University
 2010-03
NCT01273818 COMPLETED
Inguinal Hernia
Diskapi Teaching and Research Hospital
 2011-01 PHASE4
NCT00323219 COMPLETED
Cellulitis
University of British Columbia
 2004-01 PHASE3
NCT01805856 COMPLETED
Thyroid Disease; Parathyroid Disease
Ito Hospital
 2010-11
NCT00636831 COMPLETED
Inguinal Hernia
Nihon University
 2007-07 PHASE3
NCT01002911 COMPLETED
Arrythmias
Population Health Research Institute
 2009-12 PHASE3
NCT01566734 COMPLETED
Surgical Site Infections
Hormozgan University of Medical Sciences
 2010-12
NCT01295606 COMPLETED
Prophylaxis
Universitaire Ziekenhuizen KU Leuven
 2011-02 PHASE4
NCT01845363 COMPLETED
Obesity
Universidade Federal de Pernambuco
 2011-06 PHASE4
NCT01558986 COMPLETED
Surgical Infection
University of the Philippines
 2007-12 PHASE3
NCT01755026 COMPLETED
Cesarean Delivery; Wound Infection; Obesity
Michael Stitely
 2010-11 PHASE4
NCT00818766 COMPLETED
Antibiotic Prophylaxis
Brigham and Women's Hospital
 2008-03
NCT01046981 COMPLETED
Prevention of Surgical Site Infections
Klein, Jeffrey A., M.D.
 2009-03 PHASE1
NCT01867138 COMPLETED
Nosocomial Neonatal Sepsis
Hospital Italiano de Buenos Aires
 2007-03 PHASE3
NCT01401179 COMPLETED
Preterm Premature Rupture of the Membranes
Samsung Medical Center
 2005-04 PHASE3
NCT01121354 COMPLETED
Infection
B. Braun Medical Inc.
 2009-12 PHASE1
NCT00867295 COMPLETED
Solid Tumor
Istanbul University
 2008-09 PHASE3
NCT00811603 COMPLETED
Cesarean Section; Infection
MemorialCare
 2008-08 PHASE3
NCT00550290 COMPLETED
Wound Infection
Aultman Health Foundation
 2007-10 PHASE4
NCT00787553 UNKNOWN
Hysterectomy
University of Campinas, Brazil
 2006-07
NCT00438269 COMPLETED
Nosocomial Infection; Pneumonia; Systemic Inflammatory Response Syndrome; Critical Illness; Pyrexia
Canadian Critical Care Trials Group
 2003-02 PHASE2
NCT00330278 COMPLETED
Endometritis; Wound Infection
Medical University of South Carolina
 2003-01
NCT00108433 TERMINATED
Bacteremia; Gram-Positive Bacterial Infections
Pfizer
 2005-09 PHASE3
NCT00467948 COMPLETED
Laryngeal Cancer
Tehran University of Medical Sciences
 2004-06 PHASE3

(data from https://clinicaltrials.gov, updated on 2025-10-20)

Check the Cefazolin Sodium product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cefazolin sodium binds to bacterial penicillin-binding proteins, thereby blocking the final transpeptidation step of peptidoglycan synthesis required for cell wall assembly. This disruption triggers osmotic instability and bacterial cell lysis, providing broad-spectrum bactericidal efficacy to prevent post-operative wound infections and surgical site complications.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.